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Cough Capture for Lung Disease Research

This observational study, called "Cough Capture as a Portal Into the Lung," is looking for 2000 participants to help researchers understand lung diseases, including lung cancer, asthma, and COPD. The study aims to see if analyzing cough samples can provide information about your lung health, similar to more invasive procedures. Researchers will be looking for changes in your DNA (genetic material) and proteins in these cough samples. You may be eligible if you are at least 21 years old and are scheduled for a bronchoscopy (a procedure to look inside your lungs) for diagnosis or treatment, or if you have suspected asthma or COPD and are scheduled for a procedure. The study will measure the number of participants with DNA mutations and altered protein expression in their cough samples.

Study design
This is an observational study with a planned enrollment of 2000 participants. It is not a treatment study, but rather aims to collect and analyze samples.
What's involved
You would provide airway samples, which takes up to 30 minutes for collection. The study will compare cough samples to samples collected during other procedures you may be undergoing.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05854563

Cough Capture as a Portal Into the Lung

Recruiting
Not specifiedAges 21+Observational
Albert Einstein College of Medicine
~2,000 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Observational only, all subjects; measure DNA mutation and proteomic survey.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of smoker and non-smoker participants demonstrating somatic DNA mutations as evidenced by mutation burden
Measured over Up to 30 minutes for collection of all airway samples
+3 more outcomes measured

Conditions

Lung Diseases
Lung Cancer
Lung Diseases, Obstructive
Lung Diseases, Interstitial
Lung Inflammation

Explore related trials

AsthmaChronic Obstructive Pulmonary DiseaseInterstitial Lung DiseaseLung CarcinomaPneumonitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Simon D Spivack, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine

Who to contact

Aham Okorozo, MD
[email protected]
718-678-1035
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: minimum age of 21 years
Gender: Male and Female adults
Ethnicity: All ethnic groups and races
Subjects undergoing bronchoscopy for diagnostic purposes or therapy
Subjects without a known diagnosis of lung cancer who are not scheduled for lung tissue collection procedures
Subjects with a known or suspected diagnosis of asthma or COPD and are scheduled for a visit at Montefiore Asthma or COPD Center and individual practices, and/or in-hospital with exacerbation

Exclusion

Bleeding diathesis or known coagulopathy precluding clinically indicated biopsy (e.g., INR\>1.3, PTTr\>1.3), thrombocytopenia \<50,000, uremia with serum creatinine \>3.0
Unstable angina
Recent myocardial infarction (within 3 months),
Uncontrolled congestive heart failure or severe pulmonary hypertension (mean PAP\>75 mmHg)

What this trial measures

  • Number of smoker and non-smoker participants demonstrating somatic DNA mutations as evidenced by mutation burdenUp to 30 minutes for collection of all airway samples

    Somatic DNA analysis will be conducted using Single Molecule Mutation sequencing (SMM-seq) to identify mutations in EV-partitioned cough samples. The number will be determined by statistical testing using Fishers Exact Test to determine if there is a nonrandom association between the two variables

  • Aggregate Median Mutation Rate in smoker and non-smoker participantsUp to 30 minutes for collection of all airway samples

    Somatic DNA analysis will be conducted using Single Molecule Mutation sequencing (SMM-seq) to identify mutations in EV-partitioned cough samples. The aggregate median mutation rate (somatic mutation burden) in the cough from the group of smokers, as compared to that of non-smoking individuals, will be determined by statistical T-test.

  • Number of smoker and non-smoker participants demonstrating altered protein expressionUp to 30 minutes for collection of all airway samples

    Proteomic analysis will be conducted via LC-MS on the collected and EV-partitioned cough samples, MW samples, and BAL samples, respectively. To evaluate cough surrogacy for the deep lung (BAL) specimen, Spearman correlations of the most highly expressed 80 proteins among the three specimen types will be compared. The number of participant specimens demonstrating Spearman inter-tissue correlation values in excess of their corresponding threshold (0.3) will be tabulated.

  • Proteomic signature comparison in smoker and non-smoker participantsUp to 30 minutes for collection of all airway samples

    Proteomic analysis will be conducted via LC-MS on the collected and EV-partitioned cough samples, MW samples, and BAL samples, respectively. The proteomic signature of the most highly expressed 80 proteins in each of three specimen types will be compared between the current smoker and the non-smoker participants using PCA.