Melbye 1991.
Methods | RCT, 7/80 withdrawals | |
Participants | Norway: 80 adults with acute respiratory infection with more than 1 week of cough (95%) and/or dyspnoea (71%); mean duration of illness 24 days, no evidence of pneumonia, tonsillitis or sinusitis (without wheezing or dyspnoea); temp less than 38 C; baseline FEV‐1 more than 60%; 22% in fenoterol group and 19% in placebo group had wheezing on initial exam | |
Interventions | Fenoterol aerosol (0.2 mg every 6 hours) (N = 40) versus placebo aerosol (N = 40) for 7 days | |
Outcomes | Per cent change from baseline for day cough, night cough, sputum production, dyspnoea, chest pain, clamminess, fatigue; number with tremor or palpitations | |
Notes | Antibiotics allowed if begun more than 3 days prior to enrolment (40% in fenoterol group versus 28% in placebo group); other adjunctive treatments not mentioned Study medication was provided by a pharmaceutical company |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The study is described as randomised, but there is no information about the sequence generation method |
Allocation concealment (selection bias) | Unclear risk | There is no information about the method of allocation used |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Details about blinding of participants, care providers, or outcome assessors were not provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | 73 participants completed the trial (80 enrolled); information was available for only 6 of the 7 dropouts. No ITT analysis |
Selective reporting (reporting bias) | Low risk | All planned outcomes appear to have been reported |