What side effects are associated with this type of intervention?

Common treatments for mucociliary clearance, such as inhaled medications using MDI (Metered Dose Inhalers) propellants like HFO (Hydrofluoroolefin) and HFA (Hydrofluoroalkane), can have side effects including throat irritation, cough, and dry mouth. Nasal washes, often used to improve mucociliary function, may cause nasal irritation or discomfort. These treatments aim to enhance mucociliary clearance but can sometimes lead to minor, transient side effects.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving mucociliary clearance, particularly through the use of inhaled medications delivered via metered-dose inhalers (MDIs). Notable examples include short-acting beta-2 agonists like albuterol, which are commonly used to enhance mucociliary function by relaxing airway muscles and improving airflow. Additionally, inhaled corticosteroids and anticholinergic agents such as ipratropium bromide have been approved for their roles in reducing inflammation and mucus production, thereby aiding mucociliary clearance. The study of HFO MDI propellant is in line with these treatments, focusing on the efficacy and safety of different propellants in delivering these medications effectively.

What other types of research exist?

Promising alternatives to HFO MDI Propellant for mucociliary clearance patients in 2024 may include advanced drug delivery systems such as nanoemulsions, bioerodible polymers, and sustained-release implants. These systems can provide controlled and localized drug delivery, potentially improving treatment efficacy and reducing side effects. Additionally, exploring the use of novel agents like antivascular endothelial growth factor (anti-VEGF) and other anti-fibrotic agents may offer new therapeutic options.

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Inhaler Propellants for Mucociliary Clearance

Phase 3

Waitlist Available

Led By Peter Mogayzel, MD, PhD, MBA

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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two types of inhalers, one with a new propellant (HFO) and one with a standard propellant (HFA), in healthy participants. The goal is to see if the new propellant helps clear mucus from the lungs as effectively as the standard one. Participants will use each inhaler for a period of time, with a break in between, to measure and compare their effects.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 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

Change from baseline in MCC through 60 minutes following inhalation of 99m technetium-labelled colloid (sulfur or albumin) colloid and gamma camera imaging.

Secondary study objectives

Change from baseline in MCC at 3 hours following inhalation of 99m technetium-labelled colloid (sulfur or albumin)and gamma camera imaging

Other study objectives

Safety and tolerability will be evaluated in terms of AEs

Awards & Highlights

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

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

~90

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mucociliary clearance include hypertonic saline, mannitol, and mucolytic agents like N-acetylcysteine. Hypertonic saline works by drawing water into the airways, thinning mucus and making it easier to clear. Mannitol, an osmotic agent, similarly helps to hydrate and loosen mucus. Mucolytic agents like N-acetylcysteine break down the chemical structure of mucus, reducing its viscosity. These mechanisms are crucial for patients with mucociliary clearance issues as they help to maintain airway patency, reduce infection risk, and improve overall lung function. Treatments like HFO MDI propellant are being studied for their potential to enhance these effects by improving the delivery and distribution of these agents within the airways.