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TRAIL: Letrozole in Lymphangioleiomyomatosis
NCT01353209Phase 2
Key facts
- Status
- Completed
- Start
- May 2011
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- University of Cincinnati
- Modality
- Orthosteric Ligands
- Drugs
- letrozole
- Conditions
- lymphangioleiomyomatosis (LAM)
01
Overview
Phase 2, randomised, double-blind trial in lymphangioleiomyomatosis (LAM) comparing Letrozole with Placebo (2 arms). Primary endpoint: Rate of Change in Forced Expiratory Volume in 1 Second at 12 months. Started May 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Letrozole
Letrozole 2.5 mg daily
Placebo
Placebo daily
03
Who it enrols
Postmenopausal women with a definite diagnosis of LAM and impaired lung function (FEV1 <= 80% or DLCO <= 70% or RV >= 120%).
04
Endpoints
Primary
Rate of Change in Forced Expiratory Volume in 1 Second
Secondary
Post-bronchodilator Forced Vital Capacity
St George Respiratory Questionnaire
Serum Vascular Endothelial Growth Factor D
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