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Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD

Study Purpose

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. Cough in particular has a major impact on the ability to exercise, be active, and to simply enjoy life. There are many reasons for cough in ILD, and very often there are multiple overlapping causes. It is hard to improve cough in these patients, with available medicines providing limited relief. One explanation for this gap is an incomplete understanding of cough in ILD. To improve patients' cough there is a need to better understand its cause. In other lung diseases, such as asthma, doctors and scientists have used phlegm tests to measure inflammation in the lung, which helps them choose the right medicine for the right patient. This has not been done for ILD, even though it has recently been found that many patients with ILD and everyday cough have abnormal phlegm tests. Using this strategy in ILD could improve patients' cough and quality of life, and possibly even slow progression of the disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05086432
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

McMaster University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOther
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

ILD
Additional Details

SpECC-ILD is an open-label, randomized controlled trial assessing the efficacy of sputum-guided management (using sputum cytometry) compared to standard care over 16 weeks in patients with chronic cough and ILD. A total of 80 participants will be enrolled and randomized in a 1:1 ratio to either sputum guided therapy or standard of care for a total of 16 weeks. Participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation identified during screening. Participants in this arm will receive standard of care treatment as determined by their ILD specialist who will be blinded to the results of the sputum analysis.

Arms & Interventions

Arms

Experimental: Sputum-guided management

During Weeks 0 to 16, participants randomized to the intervention arm will receive open-label sputum-guided management of airway inflammation (Table 1 in protocol) identified during screening (Figure 2 in protocol). Airway eosinophilia will be treated with regular inhaled corticosteroids based on the severity of eosinophilic inflammation. In participants with airway neutrophilia, as per the standard of care, sputum culture and sensitivity will be sent, and pathogenic organisms treated. Those participants with airway neutrophilia with negative cultures will be treated with thrice weekly Azithromycin (250mg). Combined eosinophilia and neutrophilia will receive treatment with both ICS and Azithromycin as per Table 2 in protocol.

Active Comparator: Standard of Care

Participants in this arm will receive standard of care treatment as determined by their ILD specialist who will be blinded to the results of the sputum analysis.

Interventions

Other: - Sputum-guided management

As previously described.

Other: - Standard of Care

As previously described.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ciaran Scallan, MB

scallc@mcmaster.ca

9055221155

For additional contact information, you can also visit the trial on clinicaltrials.gov.