Joshi 2004.
Methods | Randomised double‐blind, placebo controlled, cross‐over study with study duration of 4 weeks. Two‐week washout period between cross‐over. Details of dropouts not clear. |
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Participants | 20 participants (9 females) age range 15 to 60 years were prospectively enrolled. All participants treated with oral salbutamol 2 mg four times daily and oral theophylline 200 mg four times daily throughout the trial period. 14 participants had unilateral disease and six had bilateral disease. Inclusion: bronchiectasis confirmed by HRCT, chest in stable state (no exacerbation in previous 1 month) demonstrating significant post‐bronchodilator response (> 12% change) on spirometry Exclusion: atopy, bronchial asthma or smoking |
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Interventions | Inhaled beclomethasone 800 µg/day in two divided doses by MDI or placebo for 4 weeks. | |
Outcomes |
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Notes | SD calculated from P value. Only first arm of the study before cross‐over used in analysis. Additional information provided by the authors. Spirometeric data not included in the analysis since baseline values not reported separately for the two groups and a common mean given for the group of 20. No mention of funding source. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information was provided within the published article about generation of randomisation. |
Allocation concealment (selection bias) | Unclear risk | No mention how allocation was done. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "patients were randomised in a double blind manner". Comment: Probably done. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of dropouts. |
Selective reporting (reporting bias) | Low risk | No suggestion that selective reporting may have been done. |
Other bias | High risk | Inclusion of participants who had a significant post‐bronchodilator response biased the study in favour of response to ICS since those with positive bronchodilator response are more likely to improve with ICS due to the asthma‐like reversibility in their airway. |