Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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.
Other: - Sputum-guided management
As previously described.
Other: - Standard of Care
As previously described.