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. 2019 Jan 31;2019(1):CD012621. doi: 10.1002/14651858.CD012621.pub2

Goudie 2014.

Methods Randomised, double‐blind, parallel‐group, placebo‐controlled trial
12 weeks duration
Participants People with COPD confirmed on respiratory function tests, and associated pulmonary hypertension, confirmed on TTE (WHO Group 3)
Inclusion criteria:
  • Men or women, aged between 35 and 85 years inclusive

  • Known diagnosis of COPD

  • A post‐bronchodilator FEV1 < 80% predicted

  • Pulmonary acceleration time < 120 ms or right ventricular systolic pressure > 30 mmHg


Exclusion criteria:
  • Pulmonary stenosis

  • Left‐ventricular outflow obstruction confirmed by echocardiography

  • Left‐ventricular systolic dysfunction (< 45%)

  • Taking nitrates, nicorandil, or doxazosin

  • Systolic blood pressure < 90 mmHg, recent stroke, unstable angina, past history of non‐arteritic anterior ischaemic optic neuropathy


Baseline characteristics: Mean FEV1 1.06 ± 0.41 L (41% pred.), mPAP 30 ± 7 mmHg (PAT derived), RVSP 42 ± 10 mmHg.
n = 120
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
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