ILDSpECC-ILDNCT05086432
Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With ILD
A study testing Sputum-guided management in people with ILD, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ILD
- What is being tested?
- Sputum-guided management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 22 May 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Pneumoconiosis
- Daily Cough for at least 8 weeks
- Able to produce an adequate sample with sputum induction
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Terence Ho, MB MSc, 905-522-1155 ext. Ext. 32995, hot4@mcmaster.ca
Terence Ho, MB MSc
About this study
Official title: Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- ILD
- Being tested
- Sputum-guided management, Standard of Care
- Keywords
- ILD, Sputum, Chronic cough
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum-guided managementOther
As previously described.
Standard of CareOther
As previously described.
| Study group | Role | What they receive |
|---|---|---|
| Sputum-guided management | Experimental | 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. Receives: Other: Sputum-guided management |
| Standard of Care | Active comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hourly cough frequency
The difference in hourly cough frequency over a 24-hour period between baseline and end of study.
Measured: 16 weeks
Secondary outcomes (11)
Change in FEV1
The difference in forced expiratory volume in 1 second (as obtained by spirometry) between baseline and end of study
Measured: 16 weeks
Change in FVC
The difference in forced vital capacity (as obtained by spirometry) between baseline and end of study
Measured: 16 weeks
Change in Leicester Cough Questionnaire
The difference in LCQ between baseline and end of study
Measured: 16 weeks
Change in King's Brief ILD Questionnaire
The difference in KB-ILD between baseline and end of study
Measured: 16 weeks
Change in sputum total cell count
The difference in sputum total cell count between baseline and end of study
Measured: 16 weeks
Change in sputum neutrophils
The difference in sputum neutrophil percent between baseline and end of study
Measured: 16 weeks
Change in sputum eosinophils
The difference in sputum eosinophil percent between baseline and end of study
Measured: 16 weeks
Adverse events
Adverse events reported by participants
Measured: 16 weeks
Serious adverse events
Serious adverse events reported by participants
Measured: 16 weeks
Completion rates for Bi-weekly LCQ
Rates of completion for bi-weekly LCQ
Measured: 16 weeks
Study medication adherence rate
Rates of adherence to study medications
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start22 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ILDStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Vitalograph
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086432
- Sponsor's protocol ID
- 13513
- Acronym
- SpECC-ILD
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sputum Cytometry Guided Management for the Elimination of Chronic Cough in Patients With Interstitial Lung Disease (SpECC-ILD) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05086432
- Acronym / sponsor ID
- SpECC-ILD / 13513
- Conditions
- ILD
- Keywords
- ILD, Sputum, Chronic cough
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Vitalograph
- Study start
- 22 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sputum-guided management | Experimental | Other: Sputum-guided managementDuring 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. |
| Standard of Care | Active comparator | Other: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum-guided managementAs previously described. | Other | Sputum-guided management |
| Standard of CareAs previously described. | Other | Standard of Care |
Primary outcome
Change in hourly cough frequency
Time frame: 16 weeks
The difference in hourly cough frequency over a 24-hour period between baseline and end of study.
11 secondary outcomes
Change in FEV1
Time frame: 16 weeks
Change in FVC
Time frame: 16 weeks
Change in Leicester Cough Questionnaire
Time frame: 16 weeks
Change in King's Brief ILD Questionnaire
Time frame: 16 weeks
Change in sputum total cell count
Time frame: 16 weeks
Change in sputum neutrophils
Time frame: 16 weeks
Change in sputum eosinophils
Time frame: 16 weeks
Adverse events
Time frame: 16 weeks
Serious adverse events
Time frame: 16 weeks
Completion rates for Bi-weekly LCQ
Time frame: 16 weeks
Study medication adherence rate
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum-guided management in people with ILD, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ciaran Scallan, MB (9055221155 ext. 34330, scallc@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hourly cough frequency (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.