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

This study has been withdrawn prior to enrollment.
(As a single center, it was not possible to recruit enough patients with pulmonary hypertension)
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Charlotte Andersen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00730067
First received: August 4, 2008
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
COPD
Pulmonary Hypertension
Drug: sildenafil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 6 minute walk test [ Time Frame: at base line, after 2 hours and after 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assessment of life quality [ Time Frame: At baseline and follow up after three months ] [ Designated as safety issue: No ]
  • Systolic pulmonary pressure [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]
  • Activity of symptoms measured by use of short acting beta agonists [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]
  • Levels of NT-proBNP and apelin [ Time Frame: At baseline and follow-up after three months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sildenafil treatment
Drug: sildenafil
Sildenafil 50 mg three times daily
Other Name: Viagra
Placebo Comparator: 2
placebo
Drug: placebo
tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730067

Locations
Denmark
Department of Pulmonary Diseases, Århus Sygehus
Århus, Denmark, Dk-8000
Department of Cardiology, Skejby sygehus
Århus N, Denmark, DK_8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Ole Hilberg, MDSC Århus Sygehus
Principal Investigator: Jens Erik Nielsen-Kudsk, MDSC Skejby Sygehus
  More Information

No publications provided

Responsible Party: Charlotte Andersen, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT00730067     History of Changes
Other Study ID Numbers: 2008-002237-73
Study First Received: August 4, 2008
Last Updated: August 22, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
COPD
Pulmonary hypertension
Sildenafil
NT-pro BNP
apelin

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 22, 2014