Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000621
First received: October 27, 1999
Last updated: January 15, 2008
Last verified: January 2008
  Purpose

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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000621     History of Changes
Other Study ID Numbers: 124
Study First Received: October 27, 1999
Last Updated: January 15, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Respiratory Tract Diseases
Isotretinoin
Tretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on July 22, 2014