Methods |
Design: randomised, double‐blind parallel study.
Method of randomisation: not stated.
Concealment of randomisation: unclear (B).
Blinding: double‐blind.
Description of withdrawals or dropouts: not stated.
Jadad's score: 2. |
Participants |
Number enrolled into trial: 49
Number in treatment groups:
Group A (salbutamol)=13
Group B (disodium cromoglycate)=12
Group C (ipratropium bromide)=12
Group D (placebo)=12
Number of withdrawals or dropouts : 17 but reason unclear.
Age (mean): 9.4 yrs (SD=2.05)
Sex: not stated.
Asthma diagnosis: Diagnosed according to ATS definition.
Severity of asthma: Asymptomatic asthma.
Inclusion criteria: All showed exercise‐induced asthma, all except 2 had atopic asthma.
Source of participants: Allergy or respiratory consultations. |
Interventions |
Types:
Group A = salbutamol 200mcg; Group B = disodium cromoglycate 20mg; Group C = ipratropium bromide 40 mcg; Group D = placebo. All medications were by inhaler at a dose of two puffs administered three times a day.
Duration: 1 month. |
Outcomes |
Outcomes: Diary records, spirometry (FEV1, PEFR), exercise test. Spirometry measured pre‐exercise and immediately post‐exercise, followed by at 5, 10, 15 and 20 minutes post exercise. |
Notes |
Study in two parts, second part relevant to this review.
Data from 32 patients only were obtained for the second part of the study (17 did not return). We are unable to report the reasons for this due to limited translation of the paper.
In addition, we suspect that there was a typing error in the paper. In the second part of the study, doses were quoted in 'mg' where we suspect 'mcg' was meant instead. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |