| Methods |
Design: randomised, double‐blind, cross‐over study.
Method of randomisation: not stated.
Concealment of randomisation: unclear (B)
Blinding: double‐blind
Description of withdrawals or dropouts: no.
Jadad's score: 2. |
| Participants |
Number enrolled into trial: 10
Number in treatment group: 10
Number in control group: 10.
Age (range): 6‐14 yrs
Age (mean): 9 yrs
Sex: 6 males, 4 females.
Asthma diagnosis: Physician diagnosed.
Severity of asthma: Moderate asthma, all except one patient on oral theophyllines, 4 pts on sodium cromoglycate (SCG), 3 on inhaled steroids.
Inclusion criteria: Chronic asthma.
Exclusion criteria: known hypersensitivity to ipratropium bromide +/‐ sympathomimetic drugs or if known cardiac disease / thyrotoxicosis or other major illnesses.
Source of participants: hospital outpatient clinic. |
| Interventions |
Setting: Home / outpatient clinic.
Types: Ipratropium bromide nebulised (125 ‐ 250mcg according to age) plus nebulised fenoterol (0.2‐0.4mg according to age) vs placebo plus fenoterol., each given three times daily.
Duration: Total 8 weeks (2 X 4 weeks).
Additional notes: No washout period stated. |
| Outcomes |
Outcome: Diary cards recording nocturnal wheeze and cough, daytime wheeze, daytime activity, sputum production and PEFRs (am and pm)
Lung function testes were performed at each of three visits (before starting trial, after the 1st month and after the 2nd month).
Adverse events: Daily diary |
| Notes |
Study in two parts, second part relevant to this review. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
