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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197469
• Other study ID #: 2008CV17
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2010
• Last updated: November 5, 2012
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• Tadalafil
Tadalafil 10mg once daily for 3 months
• Placebo

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee	Tayside

Sponsors (4)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government, NHS Fife, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life	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).	3 months	No
Secondary	B- Natriuretic Peptide (BNP)	Will be measured at 0, 2 and 3 months	3 months	No
Secondary	Diffusion lung capacity for carbon monoxide (DLCO)	Will be measured at 0 and 3 months	3 months	No
Secondary	Echocardiographic measurements	Will be measured at 0 and 3 months	3 months	No