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. Author manuscript; available in PMC: 2014 Jun 24.
Published in final edited form as: Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006826. doi: 10.1002/14651858.CD006826
Methods Parallel group study.
Randomisation: Randomised, double-blind, placebo-controlled parallel group trial.
Duration: 52 weeks.
Methods of randomisation: Computer-generated scheme at AstraZeneca, Lund, Sweden. At each centre, eligible patients received an enrolment code and then after run-in, participants were allocated the next consecutive patient number.
Allocation concealment: adequate.
Blinding: All the Turbuhaler inhalers were identical to ensure that the patient, pharmacist and the investigator were blinded to the allocated treatment
Withdrawals: Stated
Intention to treat analysis: Stated
Jadad sore: 5
Participants

  1. Setting: 89 centres in Central & South America, Europe and South Africa.

  2. Participants: 406 (BDF: 208; BUD: 198.). Additional treatment groups not covered in this review: F: 201; PLA: 205

  3. Baseline characteristics: Mean age: 64 years mean FEV1 % predicted: 36%, mean reversibility 6% predicted normal.

  4. Inclusion criteria: Age </= 40 years; COPD for </= 2 years; smoking history </= 10 pack years; FEV1 >/= 50% predicted; FEV1/FVC >/=70%; Symptom score </= 2 during at least 7 days of run-in; use of bronchodilators for reliever medication; </= 1 severe COPD exacerbation within 212 months before study entry.

  5. Exclusion criteria: history of asthma/rhinitis before age of 40; using beta-blockers; current respiratory tract disease other than COPD
Interventions Run-in: 2 weeks. Treatment with prn SABA only.

  1. BDF 320/9 mcg bid.

  2. BUD 400ug bid. Additional treatment groups not covered in this review:

  3. Placebo

  4. F 9ug bid.

Inhaler device: Turbuhaler
Outcomes Symptoms, adverse events, exacerbations, lung function.
Notes Classified as ‘poorly reversible’ subgroup. Jadad score: 5. Exacerbation defined as requirement of oral steroids and/or antibiotics and/or hospitalisation for respiratory symptoms. Mild exacerbation defined as requirement of >/= 4 inhalations per day. P values used to calculate pooled SEMs for following outcomes: Symptoms; rescue medication usage
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes As described above
Allocation concealment? Yes As described above
Blinding?
All outcomes		 Yes Identical inhaler devices