Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Oct 27, 1999

Keywords

ClinConnect Summary

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 costs the nation billions in direct and indirect health care costs. Though only about two million of the 16 million people with COPD have emphysema, emphysema is more disabling, accounting for approximately half of the 114 million days of restricted activity and half of the 53 million days of disability attributed to COPD per year. Emphysema is characterized by destruction of the air space wal...

Gender

ALL

Eligibility 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.