Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Isotretinoin; Tretinoin

Criteria

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.