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Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 28, 1999
Last Update Posted: January 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
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.

Condition Intervention Phase
Emphysema Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease Drug: all trans retinoic acid Drug: 13 cis retinoic acid Drug: placebo Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1999
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00000621     History of Changes
Other Study ID Numbers: 124
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: January 16, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents