Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 14(+/-2 days)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have been taking E/T/I medication for at least 90 days.
Select...
I have been diagnosed with cystic fibrosis.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average change in rate of mucociliary clearance (MCC) over 60 minutes from Visit 1 (pre-mannitol) to Visit 2 (post-mannitol)
Secondary outcome measures
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 moreSide effects data
From 2012 Phase 3 trial • 225 Patients • NCT0117624013%
Headache
10%
Dizziness
9%
Nausea
7%
Fatigue
6%
Hypertension
5%
Contusion
5%
Excoriation
4%
Skin laceration
4%
Diarrhoea
4%
Oedema peripheral
4%
Blood pressure increased
1%
Abdominal pain upper
1%
Faecaloma
1%
Inguinal hernia
1%
Atrial fibrillation
1%
Bronchitis viral
1%
Upper respiratory tract infection bacterial
1%
Presyncope
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Droxidopa
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.
Find a Location
Who is running the clinical trial?
Chiesi USA, Inc.Industry Sponsor
8 Previous Clinical Trials
6,079 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
19 Patients Enrolled for Cystic Fibrosis
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,017 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
31,837 Patients Enrolled for Cystic Fibrosis
Subhashini A Sellers, MD, MSCRPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can stop using hypertonic saline for 4 weeks.I am 18 years old or older.You cannot tolerate albuterol or other medicines that help open up the airways.I don't take more than 10 mg of prednisone or its equivalent daily.I've had over 2 chest CT scans or similar procedures exposing my lungs to more than 150 mSv in the last year.I will not start or stop inhaled antibiotics 7 days before my first visit and won't change them for 2 weeks after.I have not coughed up a large amount of blood recently.I haven't taken antibiotics or steroids for breathing issues in the last 28 days.I have been taking E/T/I medication for at least 90 days.You have had a bad reaction to HS or inhaled mannitol in the past.I have been diagnosed with cystic fibrosis.I cannot or will not stop taking dornase alfa and bronchodilators before my first two visits.My health has been stable for the last 28 days.Your lung function test shows that you can breathe out only a moderate amount of air.You do not smoke or vape currently.I haven't started any new long-term lung treatments for cystic fibrosis in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Inhaled Mannitol
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does the research indicate about Inhaled Mannitol's safety profile?
"The safety of Inhaled Mannitol is highly regarded, resulting in a score 3 on our scale. This treatment has been approved for use due to its successful completion of Phase 4 trials."
Answered by AI
Are new participants currently being accepted for this research undertaking?
"As reported on clinicaltrials.gov, this medical study is currently suspended of recruitment efforts; it was posted on the 3rd day of March 2021 and its status was last updated in February 13th 2023. Nonetheless, there are 424 other trials that are actively seeking participants at present."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger