NCT00104637

Brief Summary

The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

May 21, 2012

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

3.8 years

First QC Date

March 3, 2005

Results QC Date

April 4, 2012

Last Update Submit

May 18, 2012

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Keywords

Chronic Obstructive Pulmonary DiseaseEmphysemaPhosphodiesterase inhibitorsSildenafilExercise testingQuality of life

Outcome Measures

Primary Outcomes (2)

  • 6 Minute Walk Distance

    The distance a subject walked within 6 minutes was measured and documented.

    Period 1 and Period 3 ( within 8 weeks)

  • VO2 Peak (Oxygen Consumption at Peak Exercise)

    Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.

    Period 1 and Period 3 ( within 8 weeks)

Secondary Outcomes (9)

  • Pulmonary Function FVC (Forced Vital Capacity)

    Period 1 (4 weeks)

  • Forced Expiratory Volume in the First Second (FEV1 )

    Period 1 ( 4 weeks)

  • Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)

    Period 1 and Period 3 ( within 8 weeks)

  • Diffusing Capacity of Carbon Monoxide (DLCO)

    Period 1 and Period 3 ( within 8 weeks)

  • Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)

    Period 1 and Period 3 ( within 8 weeks)

  • +4 more secondary outcomes

Study Arms (2)

Sildenafil / Placebo

ACTIVE COMPARATOR

Sildenafil first, followed by washout, followed by placebo

Drug: sildenafil citrateDrug: Placebo

Placebo / Sildenafil

PLACEBO COMPARATOR

Placebo first, followed by washout, followed by Sildenafil

Drug: sildenafil citrateDrug: Placebo

Interventions

sildenafil citrateDRUG

sildenafil citrate 25 mg by mouth thrice daily (po tid)

Placebo / SildenafilSildenafil / Placebo
PlaceboDRUG

25 mg po tid

Placebo / SildenafilSildenafil / Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
  • FEV1/FVC ratio \< 70%
  • FEV1 \< 80%
  • Stable medication regimen

You may not qualify if:

  • COPD exacerbation or hospitalization in the past 3 months
  • Heart disease
  • Contraindication to sildenafil
  • Unrelated lung disease
  • Inability to walk or pedal on a stationary bike
  • Pregnancy or breast-feeding
  • Pulmonary hypertension at rest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Univeristy, College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Related Publications (1)

  • Lederer DJ, Bartels MN, Schluger NW, Brogan F, Jellen P, Thomashow BM, Kawut SM. Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial. COPD. 2012 Jun;9(3):268-75. doi: 10.3109/15412555.2011.651180. Epub 2012 Feb 23.

    PMID: 22360383DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study had slow enrollment.

Results Point of Contact

Title
David J. Lederer, MD
Organization
Columbia University
dl427@columbia.edu
212-305-7771

Study Officials

  • Steven M Kawut, M.D., M.S.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 21, 2012

Results First Posted

May 21, 2012

Record last verified: 2012-05

Locations

US(1)