Abstract
Introduction
Dry powder inhalers (DPIs) have a 20–40-fold lower carbon footprint compared to pressurized metered-dose inhalers (pMDIs). Switching from pMDI to DPI is therefore beneficial from an environmental perspective, but many health care professionals are concerned that this may worsen treatment outcomes in asthma and chronic obstructive pulmonary disease (COPD).
Methods
We analyzed patient outcomes and carbon footprints of switching inhaler treatment from pMDI to DPI. We performed a post hoc analysis on clinical outcomes data from a 12-week real-world, non-interventional study of adult patients with asthma or COPD who switched treatment from pMDI to the budesonide–formoterol Easyhaler DPI. Clinical end points included asthma control test (ACT), Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), lung function tests, and reliever use (asthma), and COPD assessment test (CAT), and modified Medical Research Council dyspnea scale (mMRC) (COPD). In the carbon footprint calculation, we used estimates from the Montreal Protocol for pMDI and for DPI the estimate as reported.
Results
Among all 237 patients (142 asthma, 95 COPD) by switching their treatment clinical improvements were observed in all the outcome measures (p < 0.001). Furthermore, the need for reliever medication decreased among patients with asthma (p < 0.001). The amount of estimated kg CO2e emissions per year for maintenance treatment was 97.0% lower for the DPI than for pMDI. For reliever medication among patients with asthma, it was 99.6% lower. Among them, the emission savings could amount to approximately 131 kg CO2e annually. This is of similar magnitude, as individual high-impact environmental actions such as eating a plant-based diet or purchasing green energy.
Conclusions
Our results show that disease control was maintained among patients with asthma or COPD when they switched from pMDI to DPI, while the carbon footprint of inhaler treatment was reduced.
Keywords: Asthma, Chronic obstructive pulmonary disease (COPD), Dry powder inhaler (DPI), Pressurized metered-dose inhaler (pMDI), Easyhaler®, Carbon footprint, Environmental sustainability
Key Summary Points
| Why carry out this study? |
| There is a call for immediate action against global warming in health care. |
| Pressurized metered-dose inhalers (pMDIs), widely used in the treatment of patients with asthma or chronic obstructive pulmonary disease (COPD), have a 20-40-fold higher carbon footprint compared to propellant-free dry powder inhalers (DPIs). |
| This post hoc analysis assessed the effect of switching from a pressurized metered-dose inhaler (pMDI) to the budesonide–formoterol Easyhaler DPI on disease control and the carbon footprint of the treatment. |
| What was learned from the study? |
| The results show improvements in clinical outcome parameters among patients with asthma or COPD when they switched from pMDI to DPI. |
| The amount of estimated kg CO2e emissions per year for maintenance treatment was 97.0% lower for the DPI than for pMDI. |
| The results strengthen the evidence on decreased environmental impact of inhaler treatment with DPIs without compromising the disease control. |
Introduction
A paper by Atwoli and coworkers in the Lancet called for immediate actions against global warming in health care [1]. Hydrofluorocarbons (HFC) are powerful greenhouse gases and because of this, EU regulation on fluorinated greenhouse gases (F-gases) aims to regulate and reduce the use of HFCs [2].
HFCs are used as propellants in pressurized metered dose inhalers (pMDIs) and because of this, pMDIs have a 20–40 fold higher carbon footprint compared to propellant-free dry powder inhalers (DPIs) [3]. Guidelines advise choosing the inhaler according to the patient, not favoring either one of the device categories [4, 5]. Most patients, even with decreased lung function, are able to use both types of devices [6]. Therefore, the selection of inhalers in the treatment of asthma and chronic obstructive pulmonary disease (COPD) is one key example of how health care professionals can help reduce greenhouse gas emissions.
In the UK, pMDIs account for approximately 70% of inhalers despite reports showing that switching from pMDI to DPI on a national level would be more sustainable and could reduce treatment costs as well [7]. Also, in most big EU countries, e.g., in Germany, France, Italy, and Spain, pMDIs are predominantly used in the treatment of obstructive pulmonary diseases. On the contrary, DPIs account for 87% of inhalers in Sweden [8, 9]. In fact, asthma control has been reported to be better than average in some countries with a high proportion of inhaled medication being delivered with DPIs than in countries where pMDIs dominate [7, 8, 10].
Different inhaler devices have their own requirements for correct use. However, most patients can use DPIs correctly and generate the sufficient inspiratory flow rate needed [6]. In a study conducted among 994 patients with asthma in the UK, each patient’s peak inspiratory flow (PIF) rate was measured according to a standard operating procedure at 2–3 different inhaler resistance settings. The results showed that 94% of patients can achieve adequate inspiratory flow to activate high-resistance DPIs [11]. Moreover, nearly a third of all patients, including a fifth of patients currently using a pMDI, failed to generate an optimal inspiratory flow to use a pMDI correctly [11]. However, in the end, patient-use factors, e.g., ease and correctness of inhaler use, preference, and satisfaction, play a major role, as they affect treatment compliance, which determines disease control and outcomes [12–14].
The treating physician’s primary concern is naturally the health benefit to the patient. Hence, physicians may be hesitant to switch their patients from the previously used pMDI to DPIs if they are not assured that their patients’ disease and symptom control is well managed. Given the increased climate awareness of health professionals and patients and the known difference in carbon footprint between the device categories, the question of whether the switch from pMDIs to DPIs is possible without compromising treatment outcomes is relevant.
To address the effect of inhaler switch on disease control and carbon footprint, we performed a post hoc analysis on a 12-week real-world, non-interventional study of adult patients with asthma or COPD who switched treatment from pMDI to budesonide–formoterol Easyhaler® DPI.
Materials and Methods
This present study is a post hoc analysis of a 12-week, real-world, multicenter, open-label, non-randomized, non-interventional, single-arm study, conducted in 200 Hungarian outpatient centers in 2016–2017 [15]. This article is based on a previously conducted study and does not contain any new studies with human participants. The original clinical study was approved by the Medical Research Council Scientific and Research Ethics Committee of Hungary and all procedures followed their ethical standards, as well as those of the 1964 Declaration of Helsinki and its later amendments. Written informed consent was obtained from all study participants prior to study commencement.
The current analysis focuses on those who switched from pMDI to budesonide–formoterol Easyhaler DPI. The daily dose and dosing regimen were agreed at the baseline visit, when patients switched to the DPI treatment, according to the judgement of the treating physician and the local guidelines. Eligible patients were ≥ 18 years of age with a diagnosis of asthma [16] or COPD [17], and without an exacerbation in the 4 weeks before enrollment. Patients were excluded if they had hypersensitivity to the study medication or excipients or were pregnant or breastfeeding.
Carbon Footprint Estimation
We used data from the Montreal Protocol [3] to calculate the carbon footprint for pMDI (0.125 kg CO2e per dose; a dose defined as two actuations or “puffs” i.e., that reported for the propellant HFC-134a containing pMDIs [3]). For DPI, the most up-to-date life cycle assessment (LCA) analysis data for budesonide–formoterol Easyhaler was used (0.00377 kg CO2e per dose) [18]. For maintenance treatment, we assumed twice-daily dosing for pMDI and DPI in both patient groups.
Clinical Endpoints
Endpoints were assessed at the 12-week visit. The primary endpoint was change in patient-reported outcome measures after 12 weeks of DPI treatment, comprising the Asthma Control Test (ACT) [16] as well as the mini-Asthma Quality of Life Questionnaire (mini-AQLQ) [19] for patients with asthma. For patients with COPD, the COPD Assessment Test (CAT) [17, 20] and modified Medical Research Council dyspnea scale (mMRC) were used. Secondary endpoints assessed disease control (using the ACT or CAT), health-related quality of life (HRQoL; using the mini AQLQ and mMRC) and forced expiratory volume in 1 s (FEV1). Patient satisfaction with their previous inhaler and the DPI device was assessed at baseline and the 12-week visit, respectively, using closed questions scored on a six-point scale (where 1 = very good and 6 = unsatisfactory) [15].
Statistical Methods
All data were expressed as percentages, median (min, max) or mean (95% confidence interval (CI)). Wilcoxon’s signed-rank test or Cochran–Mantel–Haenszel test was used to compare change from baseline for categorical variables and linear mixed model for continuous variables, with a p value < 0.05 considered statistically significant. All statistical analyses were performed using statistical analysis software (SAS), version 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).
Results
From the initial cohort of 1498 consecutive patients enrolled [15], 237 patients were using pMDI at baseline and were switched to DPI and thus included in the present analysis. Patient characteristics are presented in Table 1. At baseline, patients with asthma or COPD were treated according to local treatment practices. Inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) pMDI was used by 14% of patients with asthma and among 34% of patients with COPD before the study. Beclomethasone–formoterol comprised the most commonly used ICS/LABA pMDI treatment (11% and 13% among patients with asthma and COPD, respectively).
Table 1.
Patient baseline characteristics
| Asthma (n = 142) |
COPD (n = 95) |
Total (n = 237) |
|
|---|---|---|---|
| Age (years), mean (SD) | 51.0 (16.1) | 65.5 (10.2) | 56.9 (15.7) |
| Height (cm), mean (SD) | 165 (13.0) | 164 (8.2) | 165 (11.3) |
| Weight (kg), mean (SD) | 76.6 (20.9) | 72.9 (18.1) | 75.1 (19.8) |
| Sex (female), n (%) | 111 (78.2) | 54 (56.8) | 165 (69.6) |
| Education, n (%) | |||
| Primary school | 36 (25.4) | 53 (55.8) | 89 (37.6) |
| Secondary school | 82 (57.7) | 35 (36.8) | 117 (49.4) |
| University or college degree | 24 (16.9) | 7 (7.4) | 31 (13.1) |
| Smoking status, n (%) | |||
| Current smoker | 14 (9.9) | 45 (47.4) | 59 (24.9) |
| Previous smoker | 13 (9.2) | 34 (35.8) | 47 (19.8) |
| Never smoked | 115 (81.0) | 16 (16.8) | 131 (55.3) |
| FEV1% predicted, mean (SD) | 76.7 (17.3) | 51.3 (18.1) | 66.5 (21.6) |
There were more women among patients with asthma (69%), while patients with COPD were older, had a more frequent smoking history and had a lower degree of education compared to patients with asthma. At baseline, disease control was suboptimal in both patient groups, and hence one of the reasons for adjusting inhaler treatment.
Carbon Footprints
The greenhouse gas emission estimates were up to 46 times higher with pMDI at baseline compared to the 12-week visit when they had been using DPI (Fig. 1). The estimated annual emission for the maintenance type treatment was 91.25 kg CO2e for pMDI, and 2.75 for DPI (Fig. 1). This indicates a potential saving in emissions of 97.0% when using DPI vs. pMDI in maintenance therapy.
Fig. 1.
Carbon footprint of inhaler treatment (kg CO2e per patient per year) among patients with asthma or COPD. pMDI pressurized metered dose inhaler. DPI; dry powder inhaler. DPI used in the study was budesonide–formoterol Easyhaler. For carbon footprint calculations we used the mean value for the propellant HFC-134a containing pMDIs emissions data (0.125 kg CO2e per dose; a dose defined as two actuations or “puffs”) [3]. DPI indicates budesonide–formoterol Easyhaler for which we used the most updated estimate as reported (0.00377 kg CO2e per dose) [18]. For maintenance treatment assuming twice-daily dosing for pMDI and DPI in both patient groups. Reliever carbon footprint reported for patients with asthma (N = 142; data missing on reliever medication for two patients at baseline and one patient at the 12-week visit). The mean daily use estimates for reliever use with pMDI and DPI are reported in Table 2 and applied in carbon footprint calculations
The need for reliever medication decreased markedly among patients with asthma (Table 2). As a result, reliever related emissions decreased between baseline visit and the 12-week visit (Fig. 1). Estimated annual emissions for the reliever therapy per patient were 42.88 kg CO2e for pMDI, whereas for DPI it was only 0.15 kg CO2e (Fig. 1). A marked magnitude of the decrease of emissions at the 12-week visit was estimated at 99.6% compared to the baseline. A similar decrease was observed when analyzing those patients whose baseline treatment was ICS/LABA pMDI (31.45 kg CO2e for pMDI vs. 0.17 kg CO2e for DPI).
Table 2.
Clinical outcomes among patients with asthma (N = 142) switching from pressurized metered dose inhaler (pMDI) to dry powder inhaler (DPI)*
| Outcome parameter | Baseline visit (pMDI) | 12-week visit (DPI) | p value |
|---|---|---|---|
| ACT† mean (95% CI) | 13.3 (12.7–13.9) | 21.0 (20.6–21.5) | < .0001 |
| FEV1% mean (95% CI) | 76.7 (73.8–79.6) | 87.1 (84.1–90.0) | < .0001 |
| Mini-AQLQ‡ mean (95% CI) | 55.1 (53.0–57.2) | 78.2 (76.2–80.3) | < .0001 |
| Reliever use, N (%)§ | < .0001 | ||
| never | 12 (8.6) | 56 (39.7) | < .0001 |
| ≤ 1 per week | 13 (9.3) | 72 (51.1) | |
| 2–3 times per week | 54 (38.6) | 12 (8.5) | |
| 1–2 times per day | 48 (34.3) | 1 (0.7) | |
| ≥ 3 times per day | 13 (9.3) | 0 | |
| Reliever use per day median (min, max) § | 0.4 (0.0–3.0) | 0.1 (0.0–1.5) |
CI confidence interval
*DPI used in the study was budesonide–formoterol Easyhaler
†Asthma Control Test (ACT) scores: ≤ 15 very poorly controlled; 16–19 not well controlled, and > 20 well controlled. The minimum clinically important difference is 3 points [16]
‡Mini Asthma Quality of Life Questionnaire (mini-AQLQ) scores: a score < 4, indicating very limited daily life due to asthma. The minimum clinically important difference is ≥ 0.5 points [19]
§Data on reliever medication at baseline visit missing for two patients, and for the 12-week visit for one patient. Reliever medication use (RM) median, and range estimated as follows: never then RM = 0; ≤ 1 per week then RM = 1 per week; 2–3 times per week then RM = 2.5 per week; 1–2 times per day then RM = 1.5 per day; ≥ 3times per day then RM = 3 per day
Clinical Endpoints
At the 12-week visit, clinical outcome parameters improved significantly compared to baseline in both patient groups (Tables 2 and 3). Among patients with asthma, the mean ACT score improved from 13.3 to 21.0, as did the mean FEV1% of predicted, from 76.7 to 87.1. The mini-AQLQ score improved as well from 55.1 to 78.2 (Table 2). A marked decline in the need for reliever medication was also noted (Table 2), in line with the improved clinical outcomes and treatment control. The results were similar for male and female patients. These improvements were similar also when analyzing only those patients whose baseline treatment was ICS/LABA, with improvement in ACT score (13.8–20.4; p < 0.001), FEV1% of predicted (75.4–83.6; p = 0.0796) and mini-AQLQ score (55.2–71.8; p < 0.001).
Table 3.
Clinical outcomes among patients with COPD (N = 95) switching from pressurized metered dose inhaler (pMDI) to dry powder inhaler (DPI)
| Outcome parameter | Baseline visit (pMDI) | 12-week visit (DPI) | p value |
|---|---|---|---|
| CAT † mean (95% CI) | 23.5 (22.3–24.6) | 16.8 (15.9–17.8) | < .0001 |
| FEV1% mean (95% CI) | 51.3 (47.6–55.0) | 58.8 (55.2–62.4) | < .0001 |
| mMRC ‡ median (min, max) | 2.0 (0.0–4.0) | 1.0 (1.0–3.0) | < .0001 |
DPI used in the study was budesonide–formoterol Easyhaler
CI Confidence Interval
†COPD Assessment Test scores: a score > 20 indicating a high impact of COPD on daily life; the minimum clinically important difference is 2 or more [17, 20]
‡Modified medical research council (mMRC) dyspnea scale: score > 1 indicating difficulty in walking due to breathlessness [17]
Among patients with COPD similarly, a significant improvement was noted at the 12-week visit compared to baseline (Table 3). The mean CAT score improved from 23.5 to 16.8 as did the mean FEV1% of predicted from 51.3 to 58.8. The median mMRC score improved from 2.0 to 1.0 (Table 3). These improvements were significant (p < 0.001) also when analyzing only those patients whose baseline treatment was with ICS/LABA, with improvements in CAT score (24.5–17.4), FEV1% of predicted (50.4–58.3), and mMRC score (2.0–1.0).
Among patients with asthma, 55 (39%) patients rated their pMDI inhaler as very good or good, while 138 (99%) of them gave such a rating for DPI. For patients with COPD the corresponding ratings were 43 (45%) vs. 89 (94%).
Discussion
In the present study, we saw improvements in all clinical outcome measures for both patient groups, asthma and COPD, after the switch from pMDI to budesonide–formoterol Easyhaler DPI. Additionally, the need for reliever medication decreased among patients with asthma. Results were similar also among those who switched from ICS/LABA pMDI. Patients’ satisfaction with their inhaler increased markedly after the switch to DPI, probably partly explaining the increase seen in disease control. Furthermore, the carbon footprint of inhaler treatment decreased. Therefore, switching from pMDI to DPI is possible without compromising treatment outcomes.
To put these emission rates and potential emission savings into perspective, we can assume based on the present data that for patients with asthma, the emission savings for maintenance and reliever therapy could amount to approximately 131 kg CO2e annually for each patient. This is of similar magnitude as individual high-impact environmental actions such as eating a plant-based diet or purchasing green energy [21]. Or, compared to driving a car, this saving equals to 628 km driven with a gasoline-driven VW Golf 2020, or 1620 km driven with an electric car such as the Tesla Model 3 2020 [22].
The difference in the carbon footprint of DPIs and pMDIs has been noted already for some years and British Thoracic Society gave a recommendation to favor DPIs whenever clinically possible for environmental reasons in 2018 [23]. Since then, similar recommendations have been given in various countries in Europe [24]. Sustainability was also included in GINA 2023 to be considered whenever clinically possible [4]. Despite the guidance, treatment practices in Europe remain relatively unchanged and pMDIs still remain the most frequently used inhaler type, [8, 9]. Long-term experience with pMDIs, and the lack of experience with DPIs, both among physicians and patients may explain this hesitance for a change. However, there is increasing evidence that patients can use DPIs regardless of the severity of the disease or age [6]. One reason that can explain the reluctance to switch to DPIs may have been the difficulties in understanding the working principles, such as the internal resistance of DPI inhalers [11, 25]. High internal resistance is rather a useful tool than an obstacle, allowing for lower PIF during a successful inhalation [26]. In addition, in a recent study, 30% of patients using the inhaler resistance setting mimicking that of pMDIs failed to achieve the correct inhalation maneuver needed for successful use of the device, mainly by inhaling too forcefully and fast [11]. On the contrary, 94% of patients using the inhaler resistance setting mimicking that of DPIs succeeded in achieving adequate inspiratory flow to activate high-resistance DPIs. [11]. Additionally, many patients prefer DPIs over pMDIs [12, 13] and the use of DPIs is as easy or even easier and more reliable than that of pMDIs [14]. Multi-dose DPIs have also been reported as the most preferred device type in some studies [12–14].
The main goal in asthma and COPD treatment is good disease control. Guidance in asthma treatment highlights regular controller medication to increase disease control and decrease the need for reliever medication [4]. Frequent use of reliever medication among patients with asthma reflects poor disease management, increased risk for exacerbations with hospitalization need, and costs. Furthermore, reliever medication is still most often managed using pMDIs. In the present study, the reduction of reliever medication with pMDIs was not only beneficial for the patient but also for the environment, as it markedly reduced carbon footprint of the treatment.
This present study data derive from a real-world study conducted in Hungary during 2016–2017 [15]. It was carried out in 200 of the 550 outpatient clinics throughout the country, thus indicating a wide national coverage. Being an open-label, non-randomized, non-interventional, single-arm study, it did not have a controlled comparator group. This, however, is a built-in feature of real-world study settings that aim to interfere as little as possible with the routine clinical practice. The patient characteristics at baseline were in line with previous literature, e.g., more women than men in patients with asthma [4], and patients with COPD being older, and having a more frequent smoking history, and a lower degree of education compared to patients with asthma [17]. Patients were treated according to local treatment practices before the switch. Many patients were treated with ICS before the switch and therefore the treatment was stepped up to ICS/LABA during the study. To address this, we analyzed the clinical treatment outcomes among those switching from pMDI ICS/LABA to DPI and found similar improvements in the clinical outcome parameters as observed for the whole study population. Therefore, we do not regard this as a major limitation to conclude that the switch from pMDI to DPI is possible without a decrease in disease control.
At baseline, disease control was suboptimal in both patient groups, and hence one of the reasons for adjusting inhaler treatment. Reasons may also include incorrect patient inhaler use and inhaler satisfaction issues that could have led to poor treatment compliance [12, 13]. The relatively low patient inhaler satisfaction rating prior to switch (39–45% ranked their inhaler as good or very good) may have contributed to the poor treatment control. Patient satisfaction has been reported to lead to higher treatment compliance, which is then reflected in better treatment outcomes [12, 13]. It is possible that disease control could have improved with inhaler training for pMDIs, without the switch. However, as our aim was to show that switching from pMDI to DPI is possible without compromising treatment results, this is not relevant for the present analysis. Furthermore, our results are in line with the report by Woodcock et al., comparing both disease outcome and carbon footprint of the treatment before and after the switch from pMDIs to a DPI [27].
There are increasing data published on the environmental aspects of inhaler treatment. They convey the same message of DPIs creating less carbon footprint compared to pMDIs [8]. Companies producing inhalers are also conducting LCA studies [18, 28, 29]. LCA can provide information on many environmental measures such as the carbon footprint, water use, land use, human toxicity, and marine toxicity. However, there is still variability in the LCA analyses performed, and thus they cannot be directly compared. Hence, in the present analysis, we used data from the Montreal Protocol [3] for pMDI. For DPI, we used the latest LCA estimate for budesonide–formoterol Easyhaler [18].
There were two major limitations to our study. Firstly, real-world, pre–post design warrants cautious interpretation because such comparisons are vulnerable to multiple upward biases. In open-label settings, improvements can arise from regression to the mean after an exacerbation, secular or seasonal trends in disease activity and prescribing, changes in adherence following increased clinical attention (Hawthorne effect), and time-varying confounding by indication. These issues are particularly salient in asthma, where symptomatic endpoints often improve irrespective of active treatment. By contrast, our primary environmental endpoint—the estimated CO₂e associated with dispensed inhalers is mechanically determined by device type and estimated utilization rather than patients’ expectations; nevertheless, total real-life emissions can still be affected by concurrent changes in overall inhaler use or disease control. Importantly, our pragmatic aim was to evaluate the safety of switching in routine care; within the observed follow-up, we found no evidence of deterioration in clinical outcomes after the switch. While this design cannot exclude modest or delayed harms, the absence of a negative clinical signal is reassuring and supports the safety of switching when appropriately indicated. Secondly, the 12-week follow-up is relatively short for asthma—a chronic, relapsing disease with marked seasonality—and may be insufficient to detect infrequent outcomes (e.g., severe exacerbations) or to evaluate the durability of adherence and inhaler technique after switching. Longer observation spanning at least one annual cycle would better account for seasonal triggers (respiratory viruses, pollens) and allow assessment of sustained control and rare adverse events.
Conclusions
In the present analysis, switching patients with asthma or COPD from their previous treatment on pMDI to DPI did not decrease disease control. On the contrary, improvements were seen in clinical parameters both among all patients and among those previously on ICS/LABA treatment. In addition, the carbon footprint of the maintenance treatment decreased by 97.0% among all patients, and by 99.6% for reliever treatment among patients with asthma. Hence, according to the present results, clinicians should not worry about needing to choose between the patient and the environment.
Acknowledgements
We thank the participants of the study.
Medical Writing/Editorial Assistance
Aino Takala is acknowledged for medical writing, Mikko Vahteristo for statistical analyses, and Satu Lähelmä for editorial assistance. Aino Takala is an independent consultant. Mikko Vahteristo and Satu Lähelmä are employees of Orion Corporation.
Author Contributions
Hanna Hisinger-Mölkänen and Ville Vartiainen planned the analysis. Hanna Hisinger-Mölkänen and medical writer Aino Takala drafted the manuscript. Christer Janson, Lauri Lehtimäki, Lilla Tamasi, Ville Vartiainen and Hanna Hisinger-Mölkänen commented and revised the manuscript. All authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work, have approved the final version of the submitted manuscript, and were responsible for the decision to publish the manuscript.
Funding
The Statistical analyses, medical writing, and editorial assistance as well as the Rapid Service Fee of the journal were funded by Orion Corporation, Espoo, Finland.
Data availability
The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
Declarations
Conflict of interest
Christer Janson has received honoraria for educational activities and lectures from ALK, AstraZeneca, Chiesi, GlaxoSmithKline, Orion, Sanofi and Stallergenes, and has served on advisory boards arranged by ALK, AstraZeneca, GlaxoSmithKline, Orion, Sanofi and Stallergenes. Hanna Hisinger-Mölkänen is a former employee of Orion Corporation and reports consultation fees from AstraZeneca, Orion, MSD and GSK. Lilla Tamasi has received personal fees for lectures and advisory board meetings from AstraZeneca, Berlin Chemie, Chiesi, Orion and Sanofi. Ville Vartiainen is a former employee of Orion and has since received lecture and consultation fees from Orion Corporation. Lauri Lehtimäki has received personal fees for lectures and advisory board meetings from ALK, AstraZeneca, Berlin Chemie, Boehringer Ingelheim, Chiesi, GSK, Orion and Sanofi.
Ethical Approval
This article is based on previously conducted study and does not contain any new studies with human participants. The original clinical study was approved by the Medical Research Council Scientific and Research Ethics Committee of Hungary and all procedures followed their ethical standards, as well as those of the 1964 Declaration of Helsinki and its later amendments. Written informed consent was obtained from all study participants prior to study commencement.
Footnotes
Hanna Hisinger-Mölkänen was an employee of Orion Corporation at the time of writing this manuscript.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.