Table 2.
Key Study Design and Patient Selection Features by Study
| Study | Requirement for uncontrolled symptoms at baseline (Yes/No)a | Specific enrolment of patients with an exacerbation history? (Y/N) | Exclusion of recent exacerbations? (Y/N)c | Baseline ICS use inclusion criterion (μg/day FP equivalent (mean baseline use)) | Exclusion of patients with smoking history? (Y/N) | Concomitant asthma medications |
|---|---|---|---|---|---|---|
| FP/FORM studies | ||||||
| 1 | Not for this follow-on study. However, uncontrolled symptoms were required for entry into the parent study | No | Yes | ≤500 (NR) | Yesd | Permitted: prn salbutamol rescue Prohibited: leukotriene modifiers, LABAs, inhaled, nasal, oral or injectable corticosteroids, mucolytics, methylxanthines, sodium cromoglicate, ipratropium, tiotropium and omalizumab |
| 2 | Yes | No | Yes | ≤500 (NR) | Yesd | Permitted: prn salbutamol rescue Prohibited: leukotriene modifiers, LABAs, inhaled, nasal, oral or injectable corticosteroids, mucolytics and omalizumab |
| Lasserson et al (32) Cochrane review of single inhaler FP/SAL versus single inhaler BUD/FORM | ||||||
| Aalbers, 2004 (35) | Yes | No | Yes | 250–600 (368) | Yese | Permitted: Terbutaline or salbutamol rescue |
| Busse, 2008 (36) | Yes | No | Yes | >300–500 (NR) | Yesf | Permitted: prn SABA rescue |
| COMPASS (37) (Kuna, 2007) |
Yes | Yesb | Yes | ≥500 (374) | Nog | Permitted: Terbutaline rescue |
| EXCEL (38) (Dahl, 2006) |
Yes | No | Yes | 500–1000 (NR) | Yese | Permitted: Salbutamol rescue |
| Ducharme et al. (22) Cochrane review of ICS/LABA free combinations | ||||||
| Aubier, 1999 (39) | Yes | No | NR | 750–1000 (NR) | Noh | Permitted: prn SABA rescue Regular therapy for asthma, such as anticholinergics, theophyllines, sodium cromoglicate, continued unchanged |
| Fitzgerald, 1999 (40) | Yes | No | Yes | 200–600 (366) | Yes | Permitted: prn salbutamol In case of exacerbation, investigators could increase dose of ICS and/or add oral corticosteroid Stable doses of inhaled sodium cromoglicate, nedocromil, and oral xanthines were permitted throughout the trial, with oral antihistamines and nasal corticosteroids permitted up to 30 days (cumulative) |
| OPTIMA (18) (O'Byrne, 2001) |
Yes | No | NR | ≤400 (NR) | NR | Permitted: prn SABA rescue Prohibited: No other asthma medications allowed except in case of exacerbation |
| FACET (16) (Pauwels, 1997) |
No | No | Yes | ≤800 (419) | NR | prn SABA rescue |
| van der Molen, 1997 (41) | Yes | No | Yes | ≤800 (NR) | Yesf | Permitted: prn SABA rescue Prohibited: Sodium cromoglicate, theophylline, and anticholinergic drugs |
| Chauhan, Ducharme (33) Cochrane review of addition to ICS of LABAs versus anti-leukotrienes | ||||||
| Bjermer, 2003 (42) | Yes | No | Yes | 100–500 (324) | NR | None |
| Ilowite, 2004 (43) | Yes | No | Yes | NR | NR | prn SABA rescue |
| Price, 2011 (44) | Yes | No | Yes | Stable dose (902) | Noi | Permitted: prn inhaled SABA, ipratropium, theophylline, cromoglicate, nedocromil |
BUD, budesonide; FORM, formoterol; FP, fluticasone propionate; ICS, inhaled corticosteroid; NR, not reported; SABA, short-acting beta-agonist; SAL, salmeterol.
Defined as the use of rescue medication or asthma symptoms during the run-in period; bPatients were required to have had ≥1 asthma exacerbation in the previous 1–12 months; cExclusion of patients with a recent history of exacerbations or recent use of systemic corticosteroids;
Exclusion of patients with a smoking history >10 pack/years, and/or with a recent history of smoking (Study 1) and/or current smoking history within previous 12 months (Study 2); eExclusion of patient with a smoking history >10 pack/years; fExclusion of patients with a smoking history >20 pack/years; gIn this study 79% of patients had never smoked, 15% were previous smokers and 6% were current smokers; hIn this study, 46% of patients had never smoked, 39% were previous smokers, and 15% were current smokers; iIn this study, 41% of patients had never smoked, 42% were previous smokers, and 17% were current smokers.