The effect of deep lung support capsule in idiopathic pulmonary fibrosis

Phase 3

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis.; Idiopathic pulmonary fibrosis; J84.112

• Registration Number: IRCT20230509058135N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Forced vital capacity (FVC) greater than 40% and less than or equal to 90%
Diffusing capacity of the lungs for carbon monoxide (DLCO) greater than or equal to 40% and less than or equal to 90%

Exclusion Criteria

Having an FEV1/FVC ratio of less than 0.8 (after bronchodilator administration) at screening
Suffering from other interstitial lung diseases, history of asthma or chronic lung disease, active infection, being treated with other IPF treatment methods such as immunosuppressives and cytokine regulating agents.
History of unstable or worsening heart or lung disease (except IPF) in the past six months
Pregnant and lactating women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical symptoms (cough and shortness of breath). Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: Rate of perceived exertion and cough symptom score scales.;Pulmonary function tests. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by spirometry.;TGF-ß serum level. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by blood sample testing.