| Methods |
Design: randomised, double‐blind, cross‐over study.
Method of randomisation: not stated.
Concealment of randomisation: adequate (A) ‐ inhalers coded by manufacturers, code broken after trial completion.
Blinding: double‐blind.
Description of withdrawals or dropouts: yes.
Jadad's score: 3 |
| Participants |
Number enrolled into trial: 20
Number in treatment group: 20
Number in control group: 20
Number of withdrawals or dropouts (treatment/control): 2 (failed to keep adequate records).
Number completing trial (treatment / control): 18.
Age (range): 6‐14 yrs
Age (mean): 9.2 yrs
Sex: 9 males, 11 females.
Asthma diagnosis: Physician diagnosed.
Severity of asthma: Chronic bronchial asthma on daily medication ‐ 8 pts on regular SCG or inhaled steroids. None on oral steroids.
Inclusion criteria: Pts selected from those attending paediatric asthma clinic for > 6 months.
Source of participants: Outpatient clinic. |
| Interventions |
Setting: Home / outpatient clinic.
Types: Ipratropium bromide 40mcg (2 puffs inhaled via metered dose inhaler) TDS for 4 weeks vs placebo inhalers TDS for 4 weeks.
Duration: Total 8 weeks (2 X 4 weeks).
Additional notes: No washout period stated |
| Outcomes |
Outcomes: Diary card recording:
‐Symptoms of day and night cough and wheeze (scoring 0 for no symptoms, 1 for occasional wheeze and/or cough, 2 for troublesome wheeze and/or cough, and 3 for very ill with severe wheeze and/or cough).
‐PEFRs measured am and pm before treatment.
‐Need for additional bronchodilators
‐Need for any other drugs e.g. steroids.
Adverse events: side effects recorded in daily diary. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
