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. 2012 Jul 11;2012(7):CD002991. doi: 10.1002/14651858.CD002991.pub3

Thompson 1992.

Methods Design: parallel group
Randomisation: yes, table of random numbers
Blinding: double blind, double dummy
Withdrawals: stated
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)
Interventions BDP µg, 4 times a day ( µg/d)
Placebo 4 times a day
metered‐dose inhaler
6 weeks
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