Status:
COMPLETED
Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Emphysema
Lung Diseases
Eligibility:
All Genders
45+ years
Phase:
PHASE2
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 adm...
Detailed Description
BACKGROUND: Chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, affects more than 16 million Americans, is the fourth leading cause of death in the USA, and...
Eligibility Criteria
- Men and women > 45 years.
- Women of child-bearing potential must agree to use two forms of contraception or abstinence, and undergo monthly pregnancy testing.
- No inhaled nicotine for >= 6 months and cotinine < 20 ng/mL.
- Best FEV1 >= 25% of predicted and <= 80% of predicted on initial screening, using Hankinson's predicted values.
- DLCO <= 80% predicted on initial screening, using Crapo's predicted values (corrected for hemoglobin).
- 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.
- PCO2 < 45 mm Hg, and willingness to undergo bronchoscopy if FEV1 >= 30% of predicted.
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000621
Start Date
September 1 1999
End Date
December 1 2004
Last Update
January 16 2008
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