| Methods |
STUDY DESIGN: parallel‐group( 3), multicentre (8) in USA
RANDOMIISATION: Randomised‐ means and methods not described.
BLINDING: double‐blind, placebo controlled using 2 identical inhalers
WITHDRAWALS: 33 DESCRIBED
COMPLIANCE : Not reported in paper.
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad score = 4. COCHRANE = B |
| Participants |
N = 234, ADULT/ADOLESCENT M = 150, F = 84 Mean age = 27.3. range 12 to 73yr
BASELINE SEVERITY: Mild‐moderate asthma
INCLUSION: Baseline FEV150‐80% predicted. Diagnosis asthma by ATS definition,FEV1 reversiblility to albuterol >15%. Requiring daily beta agonist treatment during preceeeding 6 months.
EXCLUSION: smoking, theophylline and oral beta agonist |
| Interventions |
LONG ACTING BETA AGONIST : Salmeterol 42 mcg bd
SHORT ACTING BETA AGONIST :Albuterol 180 mcg qds
PLACEBO: placebo qds
DEVICE:MDI
PERIOD TREATMENT: 12 weeks
RESCUE: Albuterol 90 mcg PRN
COINTERVENTIONS: ICSS 40%, cromones 7%, |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, adverse events .
exacerbations |
| Notes |
Symtom Score‐ composite based on individual scores for breathlessness, chest tightness, wheezing, cough. Scale : 0=none to 5= severe, activities cancelled. Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
