Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
1 other identifier
interventional
120
1 country
1
Brief Summary
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Sep 2010
Typical duration for phase_2 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 6, 2012
November 1, 2012
2 years
September 1, 2010
November 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walking distance
The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months
3 months
Secondary Outcomes (4)
Quality of Life
3 months
B- Natriuretic Peptide (BNP)
3 months
Diffusion lung capacity for carbon monoxide (DLCO)
3 months
Echocardiographic measurements
3 months
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Tadalafil
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dundeelead
- Chief Scientist Office of the Scottish Governmentcollaborator
- NHS Taysidecollaborator
- NHS Fifecollaborator
Study Sites (1)
University of Dundee
Dundee, Tayside, DD1 9SY, United Kingdom
Related Publications (1)
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.
PMID: 24717626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Struthers, MBChB
University of Dundee
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 9, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 6, 2012
Record last verified: 2012-11