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Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

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ClinicalTrials.gov Identifier: NCT00000621
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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 administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : September 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
Drug Information available for: Tretinoin





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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

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