A multi-center, longitudinal 12-week pilot study to evaluate cough severity and its impact, utilizing a next generation cough monitor, in participants with idiopathic pulmonary fibrosis (IPF) or Non IPF Pulmonary Fibrosis

A multi-center, longitudinal 12-week pilot study to evaluate cough severity and its impact, utilizing a next generation cough monitor, in participants with idiopathic pulmonary fibrosis (IPF) or Non IPF Pulmonary Fibrosis - Monitoring cough in people with pulmonary fibrosis with a wearable device

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51409

Enrollment

Registered

2023-01-13

Start date

2023-02-13

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

idiopathic pulmonary fibrosis or Non IPF Pulmonary Fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Provision of signed informed consent in writing prior to study data collection 2. Subject aged 18 years or over 3. Subject diagnosed with Non IPF Pulmonary Fibrosis (>10% fibrosis on HRCT by principal investigator assessment) or IPF as per ATS/ERS/JRS/ALAT Guidelines [P22-03204] within the past 12 months 4. FVC > 40% predicted at baseline visit 5. Life expectancy > 6 months (per assessment of treating physician)

Exclusion criteria

Exclusion criteria: 1. Current smokers 2. URI or LRTI (including COVID-19 infection) within 4 weeks of screening visit 3. Airflow obstruction (FEV1/FVC

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to objectively describe cough frequency, utilizing four 24-hour cough recordings over 12 weeks in a cohort of subjects with Non IPF Pulmonary Fibrosis or IPF using the Strados RESP cough monitor. Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4 (V4), Week 8 (V5), Week 12 (V6).	—

Secondary

Measure	Time frame
Secondary endpoints include: - Change from baseline in CC/hr at Week 4, Week 8, Week 12. - FVC (mL) at baseline - FVC (mL) at Week 12 - Change from baseline in FVC (mL) at Week 12 - Feasibility of remote cough data capture (defined as % of analysable data per 24-hour recording) - Feasibility of hybrid study design (successful completion of all elements of remote visit)	—

Countries

Netherlands

Outcome results