Feldman 2010.
| Methods |
Design: 12‐week, multi‐centre, double‐blind, placebo‐controlled, parallel‐group, randomised controlled trial. Participants recruited from the United States. Additional inhaled bronchodilators other than albuterol discontinued. Run‐in: 14 days |
|
| Participants |
Population: 416 participants. Mean age 63 years. 28.9% and 34.1% of participants were taking concomitant ICS in the indacaterol and placebo arms, respectively, and mean FEV1 was 54.4% and 55.8%, respectively. Recruitment from the United States Inclusion criteria: adults > 40 years with COPD and at least a 20‐pack‐year smoking history Postbronchodilator FEV1/FVC < 70% (400 mcg salbutamol) FEV1 < 80% but > 29% Exclusion criteria: lower respiratory tract infection or hospitalisation with acute exacerbation of COPD within previous 6 weeks, asthma, any alternative significant cardiovascular or respiratory disease, type 1 or poorly controlled type 2 diabetes, history of long QT syndrome or prolonged QTc |
|
| Interventions | 1. Indacaterol 150 mcg 2. Placebo |
|
| Outcomes |
Primary outcome: trough FEV1 at 12 weeks Secondary outcomes: trough FEV1 after 1 dose and at day 29, individual time point FEV1 on day 1 and week 12, peak FEV1 on day 1 and week 12, standardised AUC FEV1 between 5 minutes and 4 hours, 5 minutes and 1 hour, 1 hour and 4 hours at week 12 Other outcomes: diary‐recorded symptoms Unspecified outcomes: SGRQ scores were not a prespecified outcome but were recorded and provided by Novartis |
|
| Notes | Trial sponsored by Novartis, which was also involved in preparation and review of the manuscript. Novartis directly supplied data for: trough FEV1, quality of life, peak FEV1. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not explicitly specified: "eligible patients were randomised using validated systems" |
| Allocation concealment (selection bias) | Low risk | Method of allocation concealment was not specified, although all study drugs were identical in appearance and administration schedule |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Excluding participant emergencies, participants, investigators, clinical staff performing assessments and data analysts and sponsors trial team; all were blinded from randomisation to database lock |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data analysts were blinded until database lock |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Rates and reasons for attrition were clearly reported: similar between groups |
| Selective reporting (reporting bias) | High risk | All prespecified outcomes were reported. SGRQ scores were recorded and provided by Novartis, although they were not a specified outcome in the manuscript |