Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

This study has been completed.

First Received: October 27, 1999 Last Updated: January 15, 2008 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000621

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 II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema

Drug Information available for: Tretinoin Isotretinoin

U.S. FDA Resources

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

Men and women > 45 years.
Women of child-bearing potential must agree to use two forms of contraception or abstinence, and undergo monthly pregnancy testing.
No inhaled nicotine for >= 6 months and cotinine < 20 ng/mL.
Best FEV1 >= 25% of predicted and <= 80% of predicted on initial screening, using Hankinson's predicted values.
DLCO <= 80% predicted on initial screening, using Crapo's predicted values (corrected for hemoglobin).
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.
PCO2 < 45 mm Hg, and willingness to undergo bronchoscopy if FEV1 >= 30% of predicted.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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

Additional relevant MeSH terms:

Emphysema
Antineoplastic Agents
Pharmacologic Actions
Keratolytic Agents
Pulmonary Emphysema
Lung Diseases, Obstructive
Pathologic Processes

Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Isotretinoin
Tretinoin
Dermatologic Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010