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

NCT00730067 | Withdrawn Phase 4 DMC

• 1 other identifier: 2008-002237-73
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD; Pulmonary Hypertension

Keywords

COPD; Pulmonary hypertension; Sildenafil; NT-pro BNP; apelin

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test

  at base line, after 2 hours and after 3 months

Secondary Outcomes (4)

• assessment of life quality

  At baseline and follow up after three months

• Systolic pulmonary pressure

  At baseline and follow-up after three months

• Activity of symptoms measured by use of short acting beta agonists

  At baseline and follow-up after three months

• Levels of NT-proBNP and apelin

  At baseline and follow-up after three months

Study Arms (2)

1

EXPERIMENTAL

Sildenafil treatment

Drug: sildenafil

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

sildenafil DRUG

Sildenafil 50 mg three times daily

Also known as: Viagra

1

placebo DRUG

tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Department of Pulmonary Diseases, Århus Sygehus

Aarhus, Dk-8000, Denmark

Location

Department of Cardiology, Skejby sygehus

Århus N, DK_8200, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ole Hilberg, MDSC

  Århus Sygehus

  PRINCIPAL INVESTIGATOR

• Jens Erik Nielsen-Kudsk, MDSC

  Skejby Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 8, 2008
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

DK (2)