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Smart cap aims to boost medication adherence in lung disease patients

NCT ID NCT07613216

Disease control Sponsor: Cosmos Rx, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test if a smart pill bottle cap, called FORTISKAP™, helps people with serious lung diseases like pulmonary fibrosis, sarcoidosis, and pulmonary hypertension take their oral medications more consistently. About 100 participants will either use the smart cap or receive usual care for nine months. The goal is to see if the device improves medication adherence and leads to better health outcomes, such as walking distance and lung function.

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 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

People with intersitial lung disease, sarcoidosis and/or pulmonary hypertension

Ages

21 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: 1. 21 years of age or older at time of enrollment 2. Primary diagnosis of interstitial lung disease (including sarcoidosis) AND/OR pulmonary hypertension 3. Currently managing their oral medications independently (i.e., without requiring caregiver administration) 4. At least one oral medication with a primary indication for treatment of ILD or PH already in use, or planned for initiation with insurance approval secured, at the time of enrollment 5. 6-Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days 6. For ILD subjects: FVC and/or DLCO scheduled within the next 30 days or performed within the past 90 days 7. For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days 8. Daily access to a smartphone compatible with the FORTISKAP™ companion application 9. Proficient in English Exclusion Criteria: Failure to meet any one of the above inclusion criteria

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis interstitial lung disease interstitial lung disease 2 Medication Adherence pulmonary hypertension pulmonary sarcoidosis sarcoidosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis (IPF) Pulmonary hypertension Sarcoidosis lung Usual interstitial pneumonia

How to take part

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

  1. The places running it

    1 site. 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

  • Pulmonary Disease Clinic, Sentara Norfolk Hospital

    Norfolk, Virginia, 23507, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.