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Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516808-42-00
Enrollment
62
Registered
2024-09-19
Start date
2022-08-18
Completion date
2024-11-29
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of loratadine in patients with lymphangioleiomyomatosis

Brief summary

Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.

Detailed description

- Maintenance of clinical stability (FEV1 drop < 10% or DLCO < 15%), - Decrease in the number of hospitalizations for any cause and respiratory causes, - Lung transplant, - Death.

Interventions

DRUGLoratadina NORMON 10 mg Comprimidos EFG

Sponsors

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.—

Secondary

MeasureTime frame
- Maintenance of clinical stability (FEV1 drop < 10% or DLCO < 15%), - Decrease in the number of hospitalizations for any cause and respiratory causes, - Lung transplant, - Death.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026