Maguire 1991.
Methods | Cross‐over RCT Power analysis: was not presented |
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Participants | Location: Valhalla, NY, USA 7 participants with COPD; mean smoking 82.8 pack‐years and onset of symptoms after age 40. 10 asthma participants were also included, but were reported separately Baseline characteristics: not reported separately for the COPD group; comparable between trial arms Setting: hospital COPD definition: 1990 ATS definition. Two of the COPD group had bronchitis and did not meet the ATS criteria of that time. Exacerbation was defined as acute onset of increasing respiratory symptoms Exclusion criteria: not able to stand unsupported next to the bed or to perform spirometry |
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Interventions | Metaproterenol in pMDI‐Spacer (2 x 0.65 mg), or handheld nebuliser (15 mg). Each participant received both devices. Treatment was separated by 2.96 ± 0.27 h (mean ± SEM) Beta2 ‐agonist: metaproterenol pMDI: brand not reported Spacer: InspirEase, Key Pharmaceuticals, Miami, FL (USA) Nebuliser: Travenol, Travenol corporation, Edison, NJ (USA) Dosage ratio spacer/nebuliser: 1:11.5 Co‐interventions: unclear Medication adherence rates: not reported |
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Outcomes | Change in FEV1, FVC and FEF 25‐75, FEV1, FVC and FEF 25‐75 Time points: each participant tested 4 times (30 min before and after each treatment) |
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Notes | Trial was supported by a grant from the National Institute of Health (NIHR) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quotation: "randomly selected" Randomisation protocol not described |
Allocation concealment (selection bias) | High risk | Randomisation protocol not described Comment: given probable lack of blinding, this also probably not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: we detected no missing data |
Selective reporting (reporting bias) | Low risk | Comment: we detected no missing outcomes |
Other bias | High risk | Compared to the other studies, a very high dosage medication by nebuliser was administered (ratio spacer/nebuliser 1:11.5). Possible sequence effect in cross‐over trial not reported upon |