BridgeMD
New treatment option for ILD
Official title Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD
ClinicalTrials.gov ID: NCT05086432
What this study is testing
- What it's testing
- In Interstitial Lung Disease (ILD) there is thickening of lung tissue, which makes it difficult for patients to breathe and get enough oxygen into their bodies. In addition to shortness of breath, daily cough is very common, with 4 out of 5 patients experiencing this symptom.
- Time commitment: about 16 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.