A multi-center, real-world exploratory cohort study to evaluate cough frequency, severity, and impact on quality of life in patients with non-idiopathic pulmonary fibrosis interstitial lung disease

A multi-center, real-world exploratory cohort study to evaluate cough frequency, severity, and impact on quality of life in patients with non-idiopathic pulmonary fibrosis interstitial lung disease - Evaluating cough and impact on quality of life in pulmonary fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51461

Enrollment

Registered

2022-04-11

Start date

2022-05-02

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

interstitial Lung disease Pulmonary fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Provision of signed informed consent in writing prior to study data collection - Subject aged 18 years or over - Subject diagnosed with non-IPF fibrosing ILD

Exclusion criteria

Exclusion criteria: - Cough due to etiology other than ILD (e.g., allergic rhinitis, Gastroesophageal Reflux Disease (GERD)) - 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 - Respiratory infection or use of antibiotics for respiratory cause within 4 weeks prior to study entry - Initiation or change in dose or type of anti-tussive medication, angiotensin-converting enzyme (ACE) inhibitors, or corticosteroids in the 4 weeks prior to study entry - Subject with airflow obstruction (forced expiratory volume in one second (FEV1)/FVC

Design outcomes

Primary

Measure	Time frame
Exposures Not applicable. Outcomes The primary outcomes of the study are the frequency of cough and the distribution of coughing fits during daytime and nighttime, in a population of subjects with non-IPF fibrosing ILDs using the first analyzable 24 hours cough recording through the VitaloJAK monitoring. The secondary outcomes of this study are: 1) variability of cough for all subjects based on two VitaloJAK recordings, 2) patient-reported impact of cough symptoms on quality of life using LCQ; 3) patient-reported cough severity, urgency, and shortness of breath using VAS; 4) patient reported impression of severity, frequency, and impact of cough using PGI index for cough symptoms reported daily over the entire study period, i.e. a period of maximum 4 weeks; 5) patient-reported overall change in cough symptoms since the beginning of the study using PGIC; 6) patient-reported overall impact of cough on quality of life using item 18 of the L-PF Impacts Questionnaire; 7) health utilities using EQ-5D-5L; and 8) measurements of physiological parameters including FVC and DLCO. Exploratory outcomes of this study are the analysis of blood and exhaled breath biomarkers. Covariates The following covariates, where available, will be collected and assessed at study enrollment: 1) subject demographics; 2) current pregnancy status; 3) time since diagnosis of non-IPF fibrosing ILD and type of non-IPF fibrosing ILD; 4) non-IPF fibrosing ILD-related medication and all concomitant medications, based on medical prescription history, in the 6 months prior to study entry and during the study period; 5) comorbidities; 6) most recent chest High-Resolution Computed Tomography (HRCT)pattern; 7) smoking status/history, number of cigarettes per day, and number of smoking years; and 8) history of COVID-19 infection and symptoms, and vaccination against COVID-19.	—

Measure

Time frame

Exposures Not applicable. Outcomes The primary outcomes of the study are the frequency of cough and the distribution of coughing fits during daytime and nighttime, in a population of subjects with non-IPF fibrosing ILDs using the first analyzable 24 hours cough recording through the VitaloJAK monitoring. The secondary outcomes of this study are: 1) variability of cough for all subjects based on two VitaloJAK recordings, 2) patient-reported impact of cough symptoms on quality of life using LCQ; 3) patient-reported cough severity, urgency, and shortness of breath using VAS; 4) patient reported impression of severity, frequency, and impact of cough using PGI index for cough symptoms reported daily over the entire study period, i.e. a period of maximum 4 weeks; 5) patient-reported overall change in cough symptoms since the beginning of the study using PGIC; 6) patient-reported overall impact of cough on quality of life using item 18 of the L-PF Impacts Questionnaire; 7) health utilities using EQ-5D-5L; and 8) measurements of physiological parameters including FVC and DLCO. Exploratory outcomes of this study are the analysis of blood and exhaled breath biomarkers. Covariates The following covariates, where available, will be collected and assessed at study enrollment: 1) subject demographics; 2) current pregnancy status; 3) time since diagnosis of non-IPF fibrosing ILD and type of non-IPF fibrosing ILD; 4) non-IPF fibrosing ILD-related medication and all concomitant medications, based on medical prescription history, in the 6 months prior to study entry and during the study period; 5) comorbidities; 6) most recent chest High-Resolution Computed Tomography (HRCT)pattern; 7) smoking status/history, number of cigarettes per day, and number of smoking years; and 8) history of COVID-19 infection and symptoms, and vaccination against COVID-19.

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Countries

Netherlands

Outcome results