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Mail-in sputum tests could simplify infection monitoring for cystic fibrosis patients

NCT ID NCT06950892

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study looks at whether adults with cystic fibrosis can collect sputum samples at home and mail them in for infection testing, compared to standard clinic collection. With 150 participants, researchers will compare how well home samples detect bacteria like Pseudomonas aeruginosa versus clinic samples. The goal is to see if remote collection is a reliable option for monitoring lung infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that home-collected sputum samples are reliable for detecting lung infections, making monitoring easier and more convenient for people with cystic fibrosis.
What could go wrong
This is an observational study, not testing a new treatment. It may find that home samples are less accurate than clinic samples, limiting their use in routine care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with cystic fibrosis from three cystic fibrosis centers

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF). * Age 18 years old or greater * People with the ability to comply with study visits and study procedures as judged by the investigator. Exclusion Criteria: * Solid organ transplant recipients, given the presence of immunosuppression. * Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration. * Subjects who do not have access to a FedEx location or pick-up services will be excluded.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis Infections infectious disease Pseudomonas infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis Infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Providence Medical Research Center

    RECRUITING

    Spokane, Washington, 99204, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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