Treating lymphangioleiomyomatosis with doxycycline

Phase 2

• Conditions: ymphangioleiomyomatosis, doxycycline, respiratory tract diseases; C04.557.375.460.465

• Registration Number: RBR-6g8yz9
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients with an established clinical-radiological or histopathological diagnosis of lymphangioleiomyomatosis

Exclusion Criteria

Patients submitted previously to lung transplant

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Variation of urinary and serum metalloproteinase (MMP) -2 and -9 levels, after doxycycline treatment, according to the levels at the time of protocol´s admission.<br><br>- Variation of FEV1 (forced expiratory volume in the first second), obtained from the difference between FEV1 after 6 months with doxycycline and the basal FEV1.

Secondary Outcome Measures

Name	Time	Method
- Lung volumes (total lung capacity and residual volume), carbon monoxide diffusion capacity and variables derivated from the six-minute walk test, such as distance walked and minimal oxyhemoglobine saturation before and after doxycycline.<br><br>- Variation of the Dessaturation- Distance Index, obtained from the ratio between desaturation area and the walked distance during six-minute walk test, after doxycicline<br><br>- Adverse events during the treatment with doxycicline