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Inhaler Propellants for Mucociliary Clearance
Phase 3
Recruiting
Led By Timothy Corcoran, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days
Awards & highlights
Study Summary
This trial studies the effects of different inhaler propellants on mucus clearance in healthy people.
Who is the study for?
Healthy adults, aged 18-60, non-smokers with a BMI of 18-35 kg/m2 and weight between 50-120 kg. They must have normal lung function (FEV1 ≥80% predicted), be able to use an MDI correctly, and comply with study requirements. Women of childbearing potential must use effective birth control and have a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing the effect of two different propellants used in metered-dose inhalers (MDIs) on mucociliary clearance in healthy participants: HFO MDI versus HFA MDI. Mucociliary clearance is how your lungs clear mucus and debris.See study design
What are the potential side effects?
Since this trial involves healthy volunteers using inhaler propellants without active medication, significant side effects are not expected. However, minor throat irritation or cough could occur due to inhaling substances from the MDI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in MCC through 60 minutes following inhalation of 99m technetium sulfur colloid and gamma camera imaging.
Secondary outcome measures
Change from baseline in MCC at 3 hours following inhalation of 99m technetium sulfur colloid and gamma camera imaging
Other outcome measures
Safety and tolerability will be evaluated in terms of AEs
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment A: HFO MDIExperimental Treatment1 Intervention
Test arm, 6 inhalations BID for 7 days
Group II: Treatment B: HFA MDIActive Control1 Intervention
Reference arm, 6 inhalations BID for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HFO MDI
2023
Completed Phase 3
~60
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,645 Total Patients Enrolled
Timothy Corcoran, PhDPrincipal InvestigatorUPMC Montefiore Hospital
Peter Mogayzel, MD, PhD, MBAPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can communicate clearly with my doctor.I am a healthy non-smoker aged 18-60 without lung problems.I haven't had any major illnesses or surgeries in the last 4 weeks.I have not had a respiratory illness in the last 30 days.I have a history of lung or breathing problems.I have not used herbal products in the last 2 weeks.I am showing signs of a COVID-19 infection.My lung function tests are within normal range.I have had cancer before, but not skin cancer.I haven't taken any respiratory or ciliary clearance medications in the last 30 days.I have previously received treatment through breathing in a special gas.I am able to understand and sign the consent form.I don't have any serious health issues that could affect the study.I haven't taken any medication in the last 14 days or within its 5 half-lives before starting the trial drug.I am a woman who can have children and my pregnancy test was negative.I am currently pregnant, breastfeeding, or planning to become pregnant.I have had COVID-19 within the last 8 weeks or during screening.I have minor health issues that could affect study results.I had a severe case of COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment B: HFA MDI
- Group 2: Treatment A: HFO MDI
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is there an age requirement for participation in this clinical experimentation?
"This trial is searching for participants who are above the legal age of consent, but below 60 years old."
Answered by AI
What kind of risks have been associated with administering HFO MDI as a form of treatment?
"We rate Treatment A: HFO MDI's safety as a 3, given its Phase 3 status and the availability of evidence supporting both efficacy and security."
Answered by AI
Could I be considered a participant in this research project?
"Qualified applicants for this medical trial must possess mucociliary clearance and fall within the age range of 18 to 60. The capacity of this research project is 30 participants in total."
Answered by AI
Is this investigation actively seeking volunteers?
"This research initiative, which was initially posted on February 24th 2023 is not currently open to candidates. The most recent update dates back to the 23rd of last month. However, there are other medical trials that remain in need of participants at this time."
Answered by AI
How many healthcare facilities are presently conducting this research?
"Currently, the project is hosted at 5 different clinics. These include Kansas City, Baltimore and Chapel Hill, along with two other sites. Choosing a nearby location will reduce travelling demands for participants."
Answered by AI
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