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

Completed

Conditions: idiopathic pulmonary fibrosis or Non IPF Pulmonary Fibrosis
10038716

Registration Number: NL-OMON51409

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

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

1. Current smokers
2. URI or LRTI (including COVID-19 infection) within 4 weeks of screening visit
3. Airflow obstruction (FEV1/FVC < 70%) at baseline or known history of
significant
spirometry response to bronchodilator
4. Cough due to etiology other than ILD (e.g., allergic rhinitis, GERD)
5. Other respiratory disorders including, but not limited to, a current
diagnosis of any
obstructive disease including chronic obstructive pulmonary disease (COPD) and
asthma, active tuberculosis, lung cancer in treatment or in medical history,
sleep
apnea, known alpha-1 antitrypsin deficiency, cor pulmonale, clinically
significant
pulmonary hypertension, clinically significant bronchiectasis, or other active
pulmonary diseases.
6. Initiation or change in dose or type of anti-tussive medication,
angiotensin-converting
enzyme (ACE) inhibitors, opiates, and systemic or inhaled (excluding intranasal)
corticosteroids in the 4 weeks prior to study entry
7. Subject with ILD exacerbation as defined by investigators within 4 weeks
prior to
study entry

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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