Phase 4
Completed N=274
Digital Auscultation Test - IPF Data Collection
Source: ClinicalTrials.gov NCT03503188 ↗Enrolled (actual)
274
Serious AEs
—
Results posted
Jan 2020
Primary outcomePrimary: Main Study - The Percentage of Collected Auscultation Points — 100; 100 PercentageOfAuscultationPointsCollected
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study - The Percentage of Collected Auscultation Points |
100; 100 | — |
| SECONDARY Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale |
29; 40; 41; 28; 31; 44 | — |
| SECONDARY Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum |
41; 64; 27; 16; 13; 27 | — |
| SECONDARY Entire Study - Smoking Status |
85; 78; 1; 26; 42; 41 | — |
| SECONDARY Entire Study - Body Mass Index (BMI) |
25.31; 23.99 | — |
| SECONDARY Sub Study - The Percentage of Collected Auscultation Points |
100; 100; 100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients
- Age ≥ 45 years at the day of the study visit
- Diagnosis:
- For patients with confirmed Idiopathic Pulmonary Fibrosis (IPF) diagnosis - a clinical diagnosis of IPF within the last 24 months from the day of the study visit, according to the American Thoracic Society (ATS)/ European Respiratory Society (ERS) 2011 guideline [P11-07084] or
- For the symptom matched control - patients without a IPF diagnosis but with one of the confirmed current conditions as:
- asthma diagnosed according to GINA guidelines,
- COPD diagnosed according to GOLD guidelines,
- pneumonia,
- upper respiratory tract infection, or
- acute bronchitis.
- Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study
Exclusion Criteria
- Any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3
- Any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative
- Patients with a history of lobectomy, pneumonectomy or lung transplant
- Patients with a Body Mass Index (BMI) >30,0 kg/m²
- Previous enrolment in this study
- Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT03503188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.