Completed

Phase 2
Age: 45Years +
All Genders
ID00000621

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2008-01-16

N/A

Participants Needed

N/A

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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