Thompson 1992.
Methods | Design: parallel group Randomisation: yes, table of random numbers Blinding: double blind, double dummy Withdrawals: stated |
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Participants | Setting: community Number eligible: not stated Number enrolled: 31 Number in treatment group: 31 in total in treatment or control groups Number in control group: 31 in total in treatment or control groups Number of withdrawals (treatment/control): 1 withdrawal (unspecified as to which group) Number completing trial (treatment/control): 20/10 Age range: mean age 50.6 yr in intervention group, mean age 47.0 yr in placebo group Sex: 15M, 15F Ethnicity: not stated COPD diagnosis: chronic bronchitis (chronic productive cough for most days of each month for at least 2 consecutive years) Severity of COPD: mean FEV1 72.6% predicted in intervention group, mean FEV1 72.0% predicted in the placebo group Inclusion criteria: current cigarette smoking, airflow obstruction with FEV1/FVC <75%, improvement of FEV1/FVC to not more than 75% with bronchodilator Exclusion criteria: seasonal or episodic dyspnoea, wheezing, atopy, other active lung disease, DLCO <50%, infiltrates on chest xray; use of oral or inhaled steroids or inhaled cromolyn within previous 3 months; carbon dioxide retention; cardiac disease or other contraindication to bronchoscopy Baseline characteristics of treatment/control groups: higher smoking history in intervention group (with similar exhaled carbon monoxide levels) |
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Interventions | BDP µg, 4 times a day ( µg/d) Placebo 4 times a day metered‐dose inhaler 6 weeks |
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Outcomes | FEV1 FVC MMEFR PEFR Sputum production Exhaled carbon monoxide levels Bronchoscopy visual bronchitis index Bronchoalveolar lavage cell count and parameter Rescue bronchodilator usage | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomised using a table of random numbers" |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double blinded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Low risk | All outcomes reported |