NCT00000621

Brief Summary

To conduct feasibility studies on the use of retinoids in the treatment of emphysema. Specific objectives are to identify optimal patient populations, retinoids, doses, dosing schedules, routes of administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

Enrollment Period

5.3 years

First QC Date

October 27, 1999

Last Update Submit

January 15, 2008

Conditions

EmphysemaLung DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease

Interventions

all trans retinoic acidDRUG
13 cis retinoic acidDRUG
placeboDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
1. Men and women \> 45 years. 2. Women of child-bearing potential must agree to use two forms of contraception or abstinence, and undergo monthly pregnancy testing. 3. No inhaled nicotine for \>= 6 months and cotinine \< 20 ng/mL. 4. Best FEV1 \>= 25% of predicted and \<= 80% of predicted on initial screening, using Hankinson's predicted values. 5. DLCO \<= 80% predicted on initial screening, using Crapo's predicted values (corrected for hemoglobin). 6. Spiral CT scan evidence of emphysema: visual impression of at least 10% emphysema on a fixed section of the total lung, and at least 10% of the lung with \< -910 HU. 7. PCO2 \< 45 mm Hg, and willingness to undergo bronchoscopy if FEV1 \>= 30% of predicted.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

EmphysemaLung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

TretinoinIsotretinoin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1999

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

January 16, 2008

Record last verified: 2008-01