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Inhaled Mannitol for Cystic Fibrosis

Phase 4

Recruiting

Led By Subhashini A Sellers, MD, MSCR

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 at the time of screening

Regularly using elexacaftor/tezacaftor/ivacaftor (E/T/I) for ≥ 90 days

Must not have

No chronic use of oral corticosteroids > 10 mg of prednisone or equivalent daily

Have had more than 2 chest computed tomography (CT) in the past year or a combination of procedures that are believed to have exposed the subject's lungs to >150 millisievert (mSv)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 14(+/-2 days)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether adding inhaled mannitol to existing E/T/I therapy in PwCF with moderate-severe disease can improve mucociliary clearance and lung function.

Who is the study for?

Adults over 18 with cystic fibrosis who've been on elexacaftor/tezacaftor/ivacaftor for at least 90 days, have an FEV1 between 30-70%, and are non-smokers. They must be stable health-wise and not on certain other treatments or medications that could affect the trial results.

What is being tested?

The study is testing if adding inhaled mannitol (Bronchitol) to patients' current regimen of elexacaftor/tezacaftor/ivacaftor can further improve mucociliary clearance in those with moderate to severe cystic fibrosis.

What are the potential side effects?

Inhaled mannitol may cause coughing, a sore throat, or bronchospasm. Since it's an inhalant, there might also be risks of respiratory tract irritation or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been taking E/T/I medication for at least 90 days.

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I have been diagnosed with cystic fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't take more than 10 mg of prednisone or its equivalent daily.

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I've had over 2 chest CT scans or similar procedures exposing my lungs to more than 150 mSv in the last year.

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I have not coughed up a large amount of blood recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 14(+/-2 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 14(+/-2 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14(+/-2 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average change in rate of mucociliary clearance (MCC) over 60 minutes from Visit 1 (pre-mannitol) to Visit 2 (post-mannitol)

Secondary study objectives

Average change in cough clearance from Visit 1 (pre-mannitol) to Visit 2 (post-mannitol)

Average change in rate of mucociliary clearance (MCC) over 90 minutes from Visit 1 (pre-mannitol) to Visit 2 (post-mannitol)

Change in forced expiratory volume in one second (FEV1) % of predicted from Visit 1 to Visit 2

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Inhaled MannitolExperimental Treatment1 Intervention

All study participants will receive the same study treatment. Study treatment will be dry powder mannitol 400 mg twice a day by oral inhalation (the contents of 10 capsules administered individually) for 14 days +/- 2 days.

0 / 6Eligibility criteria met