Status:
UNKNOWN
Effect of Loratadine in Lymphangioleiomyomatosis
Lead Sponsor:
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
Lymphangioleiomyomatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
INTRODUCTION: LAM is a rare and lethal disease characterized by progressive cystic lung destruction. Inhibition of mTOR with rapamycin is the current standard of care (SOC), which can slow-down diseas...
Detailed Description
Lymphangioleiomyomatosis (LAM) is a rare and lethal lung disease affecting almost exclusively women of childbearing age and characterized by progressive cystic lung destruction. LAM results from germl...
Eligibility Criteria
Inclusion
- 1\. Written informed consent consistent with GCP and local laws signed prior to entry into the study.
- 2\. Patients with LAM and \> 18 years-old with:
- FEV1 \> 35% and DLCO \> 20%
- Oxygen saturation (SpO2) \> 85% by pulse oximetry while breathing ambient air at rest
- Patients with a definite diagnosis consistent with LAM prior to screening based on International consensus criteria within 10 years prior to randomization
- HRCT within 12 months prior to randomization with central reading demonstrating a radiological pattern suggesting LAM and some other criteria for initiating sirolimus (symptoms, FEV1 decline or the presence of abdominal lynphangioleiomiomas).
Exclusion
- Concomitant use of other HR1 antagonist
- Hypersensitivity to HR1 antagonists
- Current smoker or ex-smoker having quit smoking \< 4 months prior to firs screening visit - Use of systemic immunosuppressants or chemotherapy within 30 days of screening.
- Receiving oral corticosteroids\>15mg/day, vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapies for LAM or administration of such therapies within 4 weeks of initial screening.
- At baseline/screening visit, values of liver transaminases above 3 times upper limit, alkaline phosphatase above 2.5 times upper limit, or bilirubin above 1.5 times upper limit
- Creatinine clearance (CrCl)\<60ml/min (determined by Cockcroft-Gault Equation) at baseline/ screening visit.
- Patients treated with strong inhibitors and inducers of CYP either during the study or 14 days prior to enrolment in the study: antifungals (e.g., ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistat, protease inhibitors (e.g., atazanavir, ritonavir, and saquinavir) and grapefruit juice, phenytoin, carbamazepine, barbiturates, rifampin.
- Current allergic asthma or other major allergic diseases that requires different daily anti- histaminic treatment.
- History of coexistent and clinically significant (in the opinion of the Investigator) chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, inadequately treated sleep- disordered breathing, or any clinically significant pulmonary diseases other than LAM.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05190627
Start Date
November 1 2021
End Date
December 30 2023
Last Update
January 27 2022
Active Locations (6)
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1
University Hospital of Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Vall d'Hebron
Barcelona, Spain
3
Hospital La Princes
Madrid, Spain
4
Hospital Puerta de Hierro
Madrid, Spain