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Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

Primary Purpose

COPD, Pulmonary Hypertension

Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Pulmonary hypertension, Sildenafil, NT-pro BNP, apelin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
  • A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
  • Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
  • Age > 18
  • Informed written consent.
  • Reliable anticonception for fertile women.

Exclusion Criteria:

  • Rheumatic disease limiting walking capacity.
  • Exacerbation in COPD during the study.
  • Age>80 years
  • FEV1 < 25 % of predicted.
  • Allergy towards contents of sildenafil or placebo tablets.
  • Fall in blood pressure of > 30 mmHg systolic or >20 mmHg diastolic after intake of the first dose of trial medication.
  • Fall in peripheral saturation of > 5% after intake of the first dose of trial medication.
  • Treatment with nitrous vasodilators or aminophyllamines.

Sites / Locations

  • Department of Cardiology, Skejby sygehus
  • Department of Pulmonary Diseases, Århus Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Sildenafil treatment

placebo

Outcomes

Primary Outcome Measures

6 minute walk test

Secondary Outcome Measures

assessment of life quality
Systolic pulmonary pressure
Activity of symptoms measured by use of short acting beta agonists
Levels of NT-proBNP and apelin

Full Information

First Posted
August 4, 2008
Last Updated
August 22, 2012
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00730067
Brief Title
Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
Official Title
Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
As a single center, it was not possible to recruit enough patients with pulmonary hypertension
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms. In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension. Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Hypertension
Keywords
COPD, Pulmonary hypertension, Sildenafil, NT-pro BNP, apelin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sildenafil treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
Sildenafil 50 mg three times daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.
Primary Outcome Measure Information:
Title
6 minute walk test
Time Frame
at base line, after 2 hours and after 3 months
Secondary Outcome Measure Information:
Title
assessment of life quality
Time Frame
At baseline and follow up after three months
Title
Systolic pulmonary pressure
Time Frame
At baseline and follow-up after three months
Title
Activity of symptoms measured by use of short acting beta agonists
Time Frame
At baseline and follow-up after three months
Title
Levels of NT-proBNP and apelin
Time Frame
At baseline and follow-up after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization. A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present. Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study. Age > 18 Informed written consent. Reliable anticonception for fertile women. Exclusion Criteria: Rheumatic disease limiting walking capacity. Exacerbation in COPD during the study. Age>80 years FEV1 < 25 % of predicted. Allergy towards contents of sildenafil or placebo tablets. Fall in blood pressure of > 30 mmHg systolic or >20 mmHg diastolic after intake of the first dose of trial medication. Fall in peripheral saturation of > 5% after intake of the first dose of trial medication. Treatment with nitrous vasodilators or aminophyllamines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Hilberg, MDSC
Organizational Affiliation
Århus Sygehus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Erik Nielsen-Kudsk, MDSC
Organizational Affiliation
Skejby Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Skejby sygehus
City
Århus N
ZIP/Postal Code
DK_8200
Country
Denmark
Facility Name
Department of Pulmonary Diseases, Århus Sygehus
City
Århus
ZIP/Postal Code
Dk-8000
Country
Denmark

12. IPD Sharing Statement

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Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

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