Phlegm test could finally silence chronic cough in lung patients
NCT ID NCT05086432
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether analyzing a patient's phlegm can help doctors choose better treatments for chronic cough in interstitial lung disease (ILD). About 120 adults with ILD and daily cough for at least 8 weeks will be randomly assigned to either phlegm-guided treatment or standard care. The goal is to see if this personalized approach reduces coughing frequency and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sputum-guided management (phlegm test to guide treatment)
- What this could lead to
- If it works, this approach could provide a more effective way to reduce chronic cough and improve quality of life for people with interstitial lung disease.
- What could go wrong
- This is a relatively small, early-stage trial (120 participants) testing a strategy rather than a new drug. The benefit may be modest, and not all patients can produce a phlegm sample.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed * Age \>18 years * A clinical diagnosis of ILD with accepted specific diagnoses including: * Idiopathic pulmonary fibrosis (IPF) * Chronic hypersensitivity pneumonitis associated ILD (CHP-ILD) * Connective tissue disease associated ILD (CTD-ILD) * Pneumoconiosis * Daily Cough for at least 8 weeks * Able to produce an adequate sample with sputum induction Exclusion Criteria: * Patients with a diagnosis of systemic sclerosis associated ILD (SSc-ILD) or sarcoidosis * Cause of cough attributed to a known etiology (ex. ACE-inhibitor, uncontrolled gastroesophageal reflux or upper airway cough syndrome, acute viral illness) * Current use of inhaled corticosteroids * Current use of systemic corticosteroids (prednisone equivalent \> 20mg/day) * Current use of chronic antibiotics * Airflow obstruction (ie. pre-bronchodilator FEV1/FVC ratio \< 0.7) * History of physician-diagnosed asthma * History of emphysema * A history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin * Moderate to severe hepatic dysfunction with a Child Pugh score \>10 * Known allergy or hypersensitivity to inhaled corticosteroids or macrolide antibiotics * Corrected QT-interval (QTc) on screening electrocardiogram (ECG) of \> 450ms * An established history of untreated atypical mycobacterial infection * A history of hearing impairment, tinnitus, or vertigo * Medication use likely to suppress cough (ex: morphine, gabapentin, amitriptyline)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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St. Joseph's Healthcare Hamilton
RECRUITINGHamilton, Ontario, L8N 4A6, Canada
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