The overall aim of this study is to assess the frequency, patient-reported severity and impact of cough, and the distribution of coughing fits during the daytime and nighttime, in a population of patients with non-IPF ILDs.Primary objective: The…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
Epidemiological data and understanding of progressive fibrosing interstitial
lung disease (PF-ILD) aside from the most common and the most severe idiopathic
pulmonary fibrosis (IPF), is very limited to date. Similar to patients with
IPF, patients with fibrosing interstitial lung diseases other than IPF (non-IPF
fibrosing ILDs), experience and report persistent cough as a common symptom.
Cough has been shown to be an independent predictor of disease progression in
patients with IPF, and it has been hypothesized that cough may enhance fibrotic
remodeling via cough induced mechanical stress. Therefore, a better
understanding of cough frequency and severity across patients with pulmonary
fibrosis and different underlying diagnoses, and its relation to functional or
imaging parameters, is important to elucidate its potential association with
disease progression in the future. Nevertheless, the incidence of persistent
and disruptive cough in the population of non-IPF fibrosing ILD patients, as
well as cough pattern and frequency, and the impact of cough on quality of
life, are not well-described.
Therefore, the aim of this study is to assess the frequency, patient-reported
severity and impact of cough on quality of life, and the distribution of
coughing fits during the daytime and nighttime, in a patient population with
non-IPF fibrosing ILDs, to expand the understanding of the disease and its
symptoms, thereby narrowing the existing gap in knowledge.
Study objective
The overall aim of this study is to assess the frequency, patient-reported
severity and impact of cough, and the distribution of coughing fits during the
daytime and nighttime, in a population of patients with non-IPF ILDs.
Primary objective:
The primary objective of this study is to objectively evaluate 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.
Secondary objectives:
The secondary objectives for this study are threefold:
1. To assess the daytime, nighttime, and 24 hours variability of cough between
the two sets of 24 hours cough recordings performed at an interval of at least
14 days
2. To estimate the severity and impact of cough symptoms on subject*s quality
of life using Leicester Cough Questionnaire (LCQ), visual analogue scales (VAS)
for cough (severity, urgency, shortness of breath), 3-item Patient Global
Impression (PGI) of Cough Symptoms assessment, Patient Global Impression of
Change (PGIC) assessment, item 18 of the Living with Pulmonary Fibrosis (L-PF)
Impacts Questionnaire, and EuroQol five dimensions five levels (EQ-5D-5L)
3. To analyze possible correlations between objective cough measurements,
patient-reported outcomes (PROs), and physiological parameters including forced
vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide
(DLCO)
Exploratory objective:
The exploratory objective of this study is to analyze possible correlations
between objective cough measurements, and blood and exhaled breath biomarkers.
Study design
A multi-center, real-world exploratory cohort study based on newly collected
data of approximately 100 evaluable subjects with non-IPF fibrosing ILDs from
various sites in the North America and Europe.
Study burden and risks
N/A
Binger Str. 173
Ingelheim am Rhein 55218
DE
Binger Str. 173
Ingelheim am Rhein 55218
DE
Listed location countries
Age
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
- 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<0.7) or known significant spirometry response to bronchodilator
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79595.099.22 |