Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Interventions: Drug: Placebo; Drug: Tadalafil

• Registration Number: NCT01197469
• Lead Sponsor: University of Dundee

Brief Summary

The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• COPD
• Forced expiratory volume in 1 second (FEV1) <80% (FEV1/FVC <0.70)
• Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time <120 ms

Exclusion Criteria

• Pulmonary stenosis or echo left ventricular outflow tract obstruction

• Left ventricular ejection fraction < 45%

• Patients taking nitrates, nicorandil or doxazosin.

• Drug contraindications:

  • Systolic Blood Pressure <90 mmHg
  • recent stroke
  • unstable angina
  • past history of non arteritic anterior ischaemic optic neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Tadalafil	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
6 minute walking distance	3 months	The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months

Secondary Outcome Measures

Name	Time	Method
B- Natriuretic Peptide (BNP)	3 months	Will be measured at 0, 2 and 3 months
Diffusion lung capacity for carbon monoxide (DLCO)	3 months	Will be measured at 0 and 3 months
Echocardiographic measurements	3 months	Will be measured at 0 and 3 months
Quality of Life	3 months	The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement).

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, Tayside, United Kingdom