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?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197469

Enrollment

120

Registered

2010-09-09

Start date

2010-09-30

Completion date

2012-09-30

Last updated

2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Keywords

Secondary Pulmonary Hypertension

Brief summary

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

Interventions

DRUGTadalafil

Tadalafil 10mg once daily for 3 months

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026