Foresi 2000.

Study characteristics
Methods	Randomised, double‐blind, placebo‐controlled, parallel‐group trial Multicentre (14) based in Italy Compared effects of 6‐month treatment with low vs standard dose budesonide in controlling symptoms and lung function in a group of asthmatic patients with moderate asthma previously treated with inhaled beclomethasone. Moreover, a comparison was made between a continued low maintenance dose of budesonide vs a short‐term increase in daily dose at the time of an asthma exacerbation. Recruitment year(s) not specified 26 weeks from baseline to endpoint
Participants	Population 213 participants were randomised to 3 treatment groups; 47 participants experienced an exacerbation; Groups 2 and 3 accounted for 36 exacerbations and contributed to the analysis. Participants were 18 to 65 years of age; mean age was 39 years; 47% were male; 70% were non‐smokers, 22% ex‐smokers, and 8% smokers. Inclusion criteria Age 18 to 65 years; baseline FEV1 ≥ 50% and ≤ 90% of predicted values; daily PEF variability ≥ 20% on at least 4 different days during a 2‐week period; daily requirement of inhaled beta‐2 agonist; presence of wheeze, cough, chest tightness, shortness of breath that interfered with normal daily activity during a 2‐week pre‐study observation period Exclusion criteria Treatment with a high dose of beclomethasone (> 1000 μg/d); history of seasonal asthma Baseline asthma severity See Table 2.
Interventions	Run‐in period 4‐week pre‐study treatment period whereby participants were asked to inhale budesonide 800 μg twice daily Study period Control arm (Group 3): maintenance inhaler of budesonide 100 μg twice daily + placebo inhaler 4 times daily for exacerbations (total 200 μg per day) Study arm (Group 2): maintenance inhaler of budesonide 100 μg twice daily + budesonide 200 μg 4 times daily for exacerbations (total 1000 μg per day) Other medications allowed Inhaled beta‐2 agonist; LABA; theophylline; anticholinergics
Outcomes	Primary outcome: not specified Secondary outcomes Number of days during which participants experienced cough, wheeze, and shortness of breath Total number of exacerbations and number of days with exacerbation during the 6‐month treatment period Number of days during which participants had a PEF value < 70% of baseline or during which they were taking oral corticosteroids was expressed as a percentage of all treatment days Number of participants with at least 1 exacerbation during the treatment period Adverse events
Notes	Funding source: Astra Farmaceutici Funder role: no details about funder's role reported. Registration: not registered Ethics approval: approved by ethics committees at all clinics Consent to participate: reports all participants provided informed consent Trial reporting vs review analysis: reports the number of participants having exacerbations defined by PEF reduction and the number of days participants had exacerbations and required OCS, but not the number of participants. Cannot be included in Analysis 1.1 or Analysis 1.2