AN INTERNATIONAL STUDY TO CHARACTERIZE THE DISEASE BEHAVIOUR OF IDIOPATHIC PULMONARY FIBROSIS AND INTERSTITIAL LUNG DISEASE DURING THE PERI-DIAGNOSTIC PERIOD
- Conditions
- idiopathic pulmonary fibrosis10024967
- Registration Number
- NL-OMON47592
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Signed Informed Consent Form
2. Able to comply with the study protocol, in the investigator*s judgment * for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires
3. Age *50 years
4. Suspicion of IPF/ILD: Radiological evidence of IPF/ILD in symptomatic patients (unexplained dyspnea on exertion and/or cough)
1. Participation in any investigational study within 28 days prior to inclusion
2. History of clinically significant cardiac disease that could explain the patient*s symptomatology in the opinion of the investigator
3. Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Decline in Forced Vital Capacity (FVC) of patients with IPF during the<br /><br>peri-diagnostic period</p><br>
- Secondary Outcome Measures
Name Time Method <p>Please refer to paragraph 6.4.2. in the protocol</p><br>