Skip to content

AN INTERNATIONAL STUDY TO CHARACTERIZE THE DISEASE BEHAVIOUR OF IDIOPATHIC PULMONARY FIBROSIS AND INTERSTITIAL LUNG DISEASE DURING THE PERI-DIAGNOSTIC PERIOD

AN INTERNATIONAL STUDY TO CHARACTERIZE THE DISEASE BEHAVIOUR OF IDIOPATHIC PULMONARY FIBROSIS AND INTERSTITIAL LUNG DISEASE DURING THE PERI-DIAGNOSTIC PERIOD - MA39297

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47592
Enrollment
15
Registered
2018-03-20
Start date
2018-06-13
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

idiopathic pulmonary fibrosis

Interventions

disease behaviour
idiopathic pulmonary fibrosis
interstitial lung disease
pulmonary function

Sponsors

Roche Nederland B.V.
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Decline in Forced Vital Capacity (FVC) of patients with IPF during the peri-diagnostic period

Secondary

MeasureTime frame
Please refer to paragraph 6.4.2. in the protocol

Countries

Canada, France, Ireland, Italy, Netherlands, Russian Federation, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)