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

Rao 2011.

Methods Randomised, double‐blind placebo‐controlled trial
12 weeks duration
Participants Inclusion criteria:
  • Ambulatory participants

  • Severe or very severe COPD (according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification)

  • Past history of smoking of at least 20 pack years

  • PASP > 40 mmHg as measured by Doppler echocardiography


Exclusion criteria:
  • An acute exacerbation of COPD in last month

  • History of bronchial asthma or > 12% increase in FEV1 with bronchodilator

  • History of primary cardiac disease or documented IHD

  • Use of nitrates or other vasodilator throughout the study period

  • Haemoglobin < 12 g/dL

  • Any severe concomitant disease

  • Evidence of PAH due to any other cause, such as pulmonary thromboembolism, HIV, scleroderma, congenital heart disease and de‐compensated right or left heart failure. (WHO Group 3)


n = 37
Interventions Oral sildenafil 20 mg 3 times a day (N=17) compared to identical placebo (N=20)
Outcomes Primary outcome: change in 6MWD. 
 Improvement in PAP was taken as secondary outcome of the study
Notes Industry provided the drugs. No other funding source stated
Trial conducted at SMS Medical College and Hospital, Jaipur (Rajasthan), India (dates of recruitment not stated)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sildenafil and placebo were dispensed according to random allocation of computer‐generated code
Allocation concealment (selection bias) Low risk Drug was dispensed by an unblinded co‐ordinator, who dispensed the drug to blinded co‐ordinator, who gave it to the participants
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Drug was dispensed by an unblinded co‐ordinator, who dispensed the drug to blinded co‐ordinator, who gave it to the participants
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not explicitly stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Withdrawals were accounted for and similar across the 2 groups ‐ where in each group 1 was lost to follow‐up, 1e in the sildenafil group had an acute exacerbation, and 1 in the placebo group withdrew consent
Selective reporting (reporting bias) Low risk Prespecified outcomes were reported
Other bias Low risk Other risk of bias is unlikely