| Methods |
Design: randomised, double‐blind, parallel study.
Method of randomisation: allocation to group by study sponsor.
Concealment of randomisation: unclear (B).
Blinding: double‐blind ‐ pharmaceutical company provided each patient with coded boxes containing drug..
Description of withdrawals or dropouts: yes.
Jadad's score: 3 |
| Participants |
Number enrolled into trial: 20
Number in treatment group (ipratropium bromide): 12
Number in control group (salbutamol): 8
Number of withdrawals or dropouts (treatment group): 3.
Number completing trial (treatment / control): 17.
Age (range): 7‐15 yrs
Sex: 14 males, 6 females.
Asthma diagnosis: Physician diagnosed.
Severity of asthma: Mild chronic symptomatic asthma
Inclusion criteria: (1) PD20 of <150mcg, (2) FEV1 and FVC > 80% of predicted, (3) FEV1/FVC >70% of predicted, (4) <20% increase in baseline FEV1 after 0.4mg of inhaled fenoterol.
Source of participants: Outpatient clinic.
Additional notes: Study performed between February and July (European study). |
| Interventions |
Setting: Home / outpatient clinic.
Types: Ipratropium bromide 40mcg (2 puffs inhaled via metered dose inhaler) TDS vs fenoterol 0.2mg via inhaler TDS.
Duration: Total 4 months. |
| Outcomes |
Outcomes: Diary card recording:
‐Symptoms of cough, wheeze and frequency of asthma attacks (score severity between 0 to 3 for each item).
‐PEFRs measured am and pm before treatment.
‐Need for additional bronchodilators
‐Need for any other drugs e.g. steroids.
At clinic (monthly assessments): PD20 and FEV1.
Adverse events: side effects recorded in daily diary. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
