Goudie 2014.
Methods | Randomised, double‐blind, parallel‐group, placebo‐controlled trial 12 weeks duration |
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Participants | People with COPD confirmed on respiratory function tests, and associated pulmonary hypertension, confirmed on TTE (WHO Group 3) Inclusion criteria:
Exclusion criteria:
Baseline characteristics: Mean FEV1 1.06 ± 0.41 L (41% pred.), mPAP 30 ± 7 mmHg (PAT derived), RVSP 42 ± 10 mmHg. n = 120 |
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Interventions | Tadalafil 10 mg daily (N=60) compared to placebo (N=60) | |
Outcomes | Primary endpoint: 6MWD Secondary endpoints: SGRQ; SF‐36 and Minnesota questionnaires (QOL); BNP DLCO and echo parameters. Inclusion: moderate‐severe COPD and PH (RVSP > 30 mmHg or a pulmonary acceleration time (PAT) < 120 ms, or both) | |
Notes | Publicly funded Trial was conducted at three centres in Scotland, UK (Dundee, Perth, and Fife), between Sept 1, 2010, and Sept 1, 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Eligible patients were randomly assigned in a 1:1 ratio, via centralised randomisation with a computer‐generated sequence and block sizes of four, to receive daily tadalafil 10 mg or matched placebo, orally" |
Allocation concealment (selection bias) | Low risk | Quote: "The intervention and placebo packs were identical in presentation (capsules and bottle) and double blinding was maintained throughout" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients, study investigators, outcome assessors, and those administering drugs were masked to group allocation. Unmasking was done only after the end of the trial once all data had been collected and analysed" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients, study investigators, outcome assessors, and those administering drugs were masked to group allocation. Unmasking was done only after the end of the trial once all data had been collected and analysed" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 120 patients were randomly assigned to receive tadalafil (n = 60) or placebo (n = 60), of whom 113 (94%) completed the study, reasons not given |
Selective reporting (reporting bias) | Low risk | Unlikely selective reporting bias |
Other bias | Low risk | Other risk unlikely |