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

This study has been completed.
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
NHS Tayside
NHS Fife
Information provided by (Responsible Party):
A. D. Struthers, University of Dundee
ClinicalTrials.gov Identifier:
NCT01197469
First received: September 1, 2010
Last updated: November 5, 2012
Last verified: November 2012

September 1, 2010
November 5, 2012
September 2010
September 2012   (final data collection date for primary outcome measure)
6 minute walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
6 minute walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
We will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
Complete list of historical versions of study NCT01197469 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).
  • B- Natriuretic Peptide (BNP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0, 2 and 3 months
  • Diffusion lung capacity for carbon monoxide (DLCO) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0 and 3 months
  • Echocardiographic measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0 and 3 months
  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We 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).
  • B- Natriuretic Peptide (BNP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0, 2 and 3 months
  • Diffusion lung capacity for carbon monoxide (DLCO) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0, 2, 3 months
  • Echocardiographic measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0 and 3 months
Not Provided
Not Provided
 
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension
  • Drug: Tadalafil
    Tadalafil 10mg once daily for 3 months
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Tadalafil
    Intervention: Drug: Tadalafil
Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01197469
2008CV17
No
A. D. Struthers, University of Dundee
University of Dundee
  • Chief Scientist Office of the Scottish Government
  • NHS Tayside
  • NHS Fife
Principal Investigator: Allan Struthers, MBChB University of Dundee
University of Dundee
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP