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Mucociliary ClearancePhase 3NCT05755932

Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants

A Phase 3 study testing HFO-1234ze(E) and HFA-134a in people with Mucociliary Clearance, run by AstraZeneca at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Study to Assess the Effect of the HFO MDI Propellant on Mucociliary Clearance Compared to the HFA MDI Propellant in Healthy Participants Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Mucociliary Clearance
What is being tested?
HFO-1234ze(E) and HFA-134a
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
5 sitesin 2 countries
Study dates
14 Jun 2023to 22 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Healthy non-smoking male and/or female participants aged 18 to 60 years inclusive at the time of signing the informed consent, without respiratory comorbidities.
  • Participant must have a forced expiratory volume in 1 second (FEV1) ≥ 80% of the predicted value for age, height, and ethnicity at screening, and FEV1/forced vital capacity (FVC) ratio of > 70%.
  • Participant must demonstrate acceptable MDI administration using empty training MDI.
  • Participant willing to comply with study IP administration requirements, defined as ≥ 80% participant medication adherence during the Treatment Periods.
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  • Body mass index (BMI) within the range 18 to 35 kg/m2 (inclusive), and weight within the range 50 to 120 kg (inclusive).
  • Female participants must be not of childbearing potential or must use a form of highly effective birth control as defined below:
  • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
  • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
  • Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. At enrollment, women of childbearing potential who are sexually active with a non-sterilized male partner should be stable on their chosen method of highly effective birth control, as defined below, and willing to remain on the birth control until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • All women of childbearing potential must have a negative serum pregnancy test result at Visit 1.
  • Females <50 years of age with amenorrhea for 12 months without an alternative medical cause must have a serum FSH test at Visit 1.
  • Highly effective birth control methods are listed below:
  • Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • Oral
  • Intravaginal
  • Transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation:
  • Oral
  • Injectable
  • Implantable
  • Intrauterine device or intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis or medical history interview provided by her or her partner.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • History of smoking > 10 pack-years, or participant quit smoking < 6 months prior to screening.
  • Acute or chronic upper or lower respiratory illness within 30 days of screening.
  • Respiratory medication or medication impacting ciliary clearance for any indication within 30 days of screening.
  • History of more than 2 chest CTs or equivalent (> 10 mSv) within the past year.
  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
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  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the IP.
  • History of any cancer except squamous cell and basal cell carcinomas of the skin.
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
  • Any clinically significant abnormal findings in vital signs at screening, as judged by the investigator.
  • Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator. Note: Participants with ECG QT interval corrected for heart rate using Fridericia's formula (QTcF) > 480 msec will be excluded.
  • A SARS-CoV-2 infection in the 8 weeks prior to Visit 1, or during the Screening Period, or that required hospitalization at any time prior to Visit 1 or during the Screening Period.
  • Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection; eg, fever, dry cough, dyspnea, sore throat, fatigue, or laboratory-confirmed acute infection with SARS-CoV-2.
  • Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
  • History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis, alpha-1 antitrypsin, primary ciliary dyskinesia, cystic fibrosis.
  • Known or suspected history of drug abuse, as judged by the investigator.
  • Current smokers or those who have smoked or used nicotine products (including electronic cigarettes) marijuana, vaping, etc, within the 6 months prior to screening.
  • Positive screen for drugs of abuse or cotinine at screening.
  • Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose of vitamins (intake of 20 to 600 times the recommended daily dose), and minerals within 14 days or 5 half-lives (whichever is longer) prior to the first administration of IP.
  • Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (eg, > 5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages.
  • Using any herbal products either by inhalation or by nebulizer within 2 weeks of Visit 1, and does not agree to stop for the duration of the study.
  • Participation in another clinical study with an IP administered in the last 30 days or 5 half-lives, whichever is longer.
  • Involvement of any AstraZeneca, Fortrea, or study site employee or their close relatives.
  • Participants who have previously received HFO via inhalation (eg, BGF [also known as PT010, Breztri, Trixeo] HFO).
  • Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
  • Participants who cannot communicate reliably with the investigator.
  • Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or judicial order.
  • Female participants who are currently pregnant (confirmed with positive pregnancy test), breast feeding, or planned pregnancy during the study or women of childbearing potential not using acceptable contraception measures (see Inclusion Criterion).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Research Site

    Baltimore, Maryland, 21287

  • Research Site

    Chapel Hill, North Carolina, 27599

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

United Kingdom1 site

  • Research Site

    Glasgow, G4 0SF

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Two-way Crossover Study to Assess the Effect of Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) on Mucociliary Clearance Compared With Hydrofluoroalkane (HFA) Propellant MDI in Healthy Participants

A Study to Assess the Effect of the HFO MDI Propellant on Mucociliary Clearance Compared to the HFA MDI Propellant in Healthy Participants

Read the detailed description

A randomized, double-blind, multi-site, two-way crossover study to assess the effect on MCC and safety of HFO propellant compared to HFA propellant in healthy participants. Mucociliary clearance will be determined after 1 week of twice daily (BID) administration of HFO MDI (test) and HFA MDI (reference).

The study will comprise a Screening Period 7 to 14 days prior to first dosing; Two Treatment Periods (TPs) of 7 days each (+ up to 3 days), with a 7 to 14 day Washout Period between the 2 TPs; and a final safety Follow-up Visit 5 to 7 days after the final dose administration in TP2.

Participants will receive treatments in 1 of 2 possible treatment sequences: A followed by B, or B followed by A.

Study treatment will be administered via MDI device as 6 inhalations BID (every morning and evening approximately 12 hours apart):

Treatment A: HFO MDI; 6 inhalations per dose - test formulation Treatment B: HFA MDI; 6 inhalations per dose - reference formulation

Being tested
HFO-1234ze(E), HFA-134a
Keywords
Mucociliary Clearance, Propellant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFO-1234ze(E)Drug

    Also called Propellant in MDI

    • Dose formulation: metered dose inhaler (MDI)
    • Unit dose strength(s): Experimental (propellant only)
    • Dosage level(s): 6 inhalations, BID
    • Route of administration: Oral inhalation
    • Participants will receive treatment A in 1 of 2 possible treatment sequences: AB or BA

  • HFA-134aDrug

    Also called Propellant in MDI

    • Dose formulation: metered dose inhaler (MDI)
    • Unit dose strength(s): Reference (propellant only)
    • Dosage level(s): 6 inhalations, BID
    • Route of administration: Oral inhalation
    • Participants will receive treatment B in 1 of 2 possible treatment sequences: AB or BA.
Study groups in NCT05755932
Study groupRoleWhat they receive
Treatment A: HFO MDIExperimentalTest arm, 6 inhalations BID for 7 days
Receives: Drug: HFO-1234ze(E)
Treatment B: HFA MDIActive comparatorReference arm, 6 inhalations BID for 7 days
Receives: Drug: HFA-134a

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 7 days

Secondary outcomes (1)

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

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

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start14 Jun 2023
  3. Primary completion22 Jul 2024
  4. Study completion22 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
A randomized, double-blind, multi-site, two-way crossover study to assess the effect on MCC and safety of HFO propellant compared to HFA propellant in healthy participants. Mucociliary clearance will be determined after 1 week of twice daily (BID) administration of HFO MDI (test) and HFA MDI (reference). Study treatment will be administered via MDI device as 6 inhalations BID Participants will receive treatments in 1 of 2 possible treatment sequences: A followed by B, or B followed by A. * Treatment A: HFO MDI - test formulation * Treatment B: HFA MDI - reference formulation The study will comprise * A Screening Period 7 to 14 days prior to first dosing; * Two Treatment Periods (TPs) of 7 days each, a 7 to 14 day Washout Period between the 2 TPs; and * A final safety Follow-up Visit
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755932
Sponsor's protocol ID
D5985C00006
Status last verified
Nov 2025
First submitted
23 Feb 2023
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Donaldson SH, Zeman KL, Bell A, Jassal M, Pandya H, Bell JL, Puu M, Aurivillius M, Patel M, Bennett W. Mucociliary Clearance Following a Next-Generation Propellant Versus Hydrofluoroalkane-134a via Pressurized Metered-Dose Inhaler: A Randomized, Double-Blind, Two-Way Crossover Study in Healthy Adults. J Aerosol Med Pulm Drug Deliv. 2026 Jul 16:19412711261470884. doi: 10.1177/19412711261470884. Online ahead of print.

    PubMed 42461285

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HFO-1234ze(E) and HFA-134a in people with Mucociliary Clearance, run by AstraZeneca at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in MCC through 60 minutes following inhalation of 99m technetium-labelled colloid (sulfur or albumin) colloid and gamma camera imaging. (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755932, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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