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Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD (SpECC-ILD)

Primary Purpose

ILD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sputum-guided management
Standard of Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ILD focused on measuring ILD, Sputum, Chronic cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sputum-guided management

    Standard of Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in hourly cough frequency
    The difference in hourly cough frequency over a 24-hour period between baseline and end of study.

    Secondary Outcome Measures

    Change in FEV1
    The difference in forced expiratory volume in 1 second (as obtained by spirometry) between baseline and end of study
    Change in FVC
    The difference in forced vital capacity (as obtained by spirometry) between baseline and end of study
    Change in Leicester Cough Questionnaire
    The difference in LCQ between baseline and end of study
    Change in King's Brief ILD Questionnaire
    The difference in KB-ILD between baseline and end of study
    Change in sputum total cell count
    The difference in sputum total cell count between baseline and end of study
    Change in sputum neutrophils
    The difference in sputum neutrophil percent between baseline and end of study
    Change in sputum eosinophils
    The difference in sputum eosinophil percent between baseline and end of study
    Adverse events
    Adverse events reported by participants
    Serious adverse events
    Serious adverse events reported by participants
    Completion rates for Bi-weekly LCQ
    Rates of completion for bi-weekly LCQ
    Study medication adherence rate
    Rates of adherence to study medications

    Full Information

    First Posted
    September 28, 2021
    Last Updated
    June 8, 2023
    Sponsor
    McMaster University
    Collaborators
    St. Joseph's Healthcare Hamilton, Vitalograph
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05086432
    Brief Title
    Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD
    Acronym
    SpECC-ILD
    Official Title
    Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    St. Joseph's Healthcare Hamilton, Vitalograph

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ILD
    Keywords
    ILD, Sputum, Chronic cough

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sputum-guided management
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Sputum-guided management
    Intervention Description
    As previously described.
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    As previously described.
    Primary Outcome Measure Information:
    Title
    Change in hourly cough frequency
    Description
    The difference in hourly cough frequency over a 24-hour period between baseline and end of study.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Change in FEV1
    Description
    The difference in forced expiratory volume in 1 second (as obtained by spirometry) between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in FVC
    Description
    The difference in forced vital capacity (as obtained by spirometry) between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in Leicester Cough Questionnaire
    Description
    The difference in LCQ between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in King's Brief ILD Questionnaire
    Description
    The difference in KB-ILD between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in sputum total cell count
    Description
    The difference in sputum total cell count between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in sputum neutrophils
    Description
    The difference in sputum neutrophil percent between baseline and end of study
    Time Frame
    16 weeks
    Title
    Change in sputum eosinophils
    Description
    The difference in sputum eosinophil percent between baseline and end of study
    Time Frame
    16 weeks
    Title
    Adverse events
    Description
    Adverse events reported by participants
    Time Frame
    16 weeks
    Title
    Serious adverse events
    Description
    Serious adverse events reported by participants
    Time Frame
    16 weeks
    Title
    Completion rates for Bi-weekly LCQ
    Description
    Rates of completion for bi-weekly LCQ
    Time Frame
    16 weeks
    Title
    Study medication adherence rate
    Description
    Rates of adherence to study medications
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ciaran Scallan, MB
    Phone
    9055221155
    Ext
    34330
    Email
    scallc@mcmaster.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Terence Ho, MB, MSc
    Phone
    9055221155
    Ext
    32995
    Email
    hot4@mcmaster.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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