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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Tadalafil

Placebo

Sponsored by

University of Dundee

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Secondary Pulmonary Hypertension

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Dundee

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Tadalafil

Arm Description

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

B- Natriuretic Peptide (BNP)

Will be measured at 0, 2 and 3 months

Diffusion lung capacity for carbon monoxide (DLCO)

Will be measured at 0 and 3 months

Echocardiographic measurements

Will be measured at 0 and 3 months

Full Information

NCT ID

First Posted

September 1, 2010

Last Updated

November 5, 2012

Sponsor

University of Dundee

Collaborators

Chief Scientist Office of the Scottish Government, NHS Tayside, NHS Fife

1. Study Identification

Unique Protocol Identification Number

NCT01197469

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Dundee

Collaborators

Chief Scientist Office of the Scottish Government, NHS Tayside, NHS Fife

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Keywords

Secondary Pulmonary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Tadalafil

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tadalafil

Intervention Description

Tadalafil 10mg once daily for 3 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

6 minute walking distance

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Quality of Life

Description

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).

Time Frame

3 months

Title

B- Natriuretic Peptide (BNP)

Description

Will be measured at 0, 2 and 3 months

Time Frame

3 months

Title

Diffusion lung capacity for carbon monoxide (DLCO)

Description

Will be measured at 0 and 3 months

Time Frame

3 months

Title

Echocardiographic measurements

Description

Will be measured at 0 and 3 months

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan Struthers, MBChB

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Dundee

City

Dundee

State/Province

Tayside

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24717626

Citation

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.

Results Reference

derived

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

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