Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants
NCT ID: NCT05755932
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2023-06-14
2024-07-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants
NCT06506266
Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma
NCT05850494
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
NCT00667992
A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma
NCT06702462
A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
NCT05472662
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
* 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
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A: HFO MDI
Test arm, 6 inhalations BID for 7 days
HFO-1234ze(E)
* 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
Treatment B: HFA MDI
Reference arm, 6 inhalations BID for 7 days
HFA-134a
* 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HFO-1234ze(E)
* 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-134a
* 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 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.
2. 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.
3. 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%.
4. Participant must demonstrate acceptable MDI administration using empty training MDI.
5. Participant willing to comply with study IP administration requirements, defined as ≥ 80% participant medication adherence during the Treatment Periods.
6. Body mass index (BMI) within the range 18 to 35 kg/m2 (inclusive), and weight within the range 50 to 120 kg (inclusive).
7. Female participants must be not of childbearing potential or must use a form of highly effective birth control as defined below:
(a) 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.
8. 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.
Exclusion Criteria
1. History of smoking \> 10 pack-years, or participant quit smoking \< 6 months prior to screening.
2. Acute or chronic upper or lower respiratory illness within 30 days of screening.
3. Respiratory medication or medication impacting ciliary clearance for any indication within 30 days of screening.
4. History of more than 2 chest CTs or equivalent (\> 10 mSv) within the past year.
5. 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.
6. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the IP.
7. History of any cancer except squamous cell and basal cell carcinomas of the skin.
8. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
9. Any clinically significant abnormal findings in vital signs at screening, as judged by the investigator.
10. 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.
11. 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.
12. 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.
13. Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
14. History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis, alpha-1 antitrypsin, primary ciliary dyskinesia, cystic fibrosis.
15. Known or suspected history of drug abuse, as judged by the investigator.
16. Current smokers or those who have smoked or used nicotine products (including electronic cigarettes) marijuana, vaping, etc, within the 6 months prior to screening.
17. Positive screen for drugs of abuse or cotinine at screening.
18. 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.
19. 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.
20. 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.
21. Participation in another clinical study with an IP administered in the last 30 days or 5 half-lives, whichever is longer.
22. Involvement of any AstraZeneca, Fortrea, or study site employee or their close relatives.
23. Participants who have previously received HFO via inhalation (eg, BGF \[also known as PT010, Breztri, Trixeo\] HFO).
24. 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.
25. Participants who cannot communicate reliably with the investigator.
26. Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or judicial order.
27. 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).
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William D Bennett, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Andreas Schmid, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Timothy Corcoran, PhD
Role: PRINCIPAL_INVESTIGATOR
UPMC Montefiore Hospital
Peter Mogayzel, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Douglas Conrad, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Kansas City, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Glasgow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
Investigator's Brochure - Budesonide, Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (BGF MDI); Budesonide and Formoterol Fumarate Inhalation Aerosol (BFF MDI); Budesonide Inhalation Aerosol (BD MDI); Glycopyrronium Inhalation Aerosol (GP MDI) (Also known as PT010 [BGF MDI], PT009 [BFF MDI], PT008 (BD MDI); PT001 (GP MDI); Edition Number 8.0, 22 April 2020.
Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
Laube BL, Carson KA, Sharpless G, Paulin LM, Hansel NN. Mucociliary Clearance in Former Tobacco Smokers with Both Chronic Obstructive Pulmonary Disease and Chronic Bronchitis and the Effect of Roflumilast. J Aerosol Med Pulm Drug Deliv. 2019 Aug;32(4):189-199. doi: 10.1089/jamp.2018.1459. Epub 2019 Apr 8.
Bennett WD, Wu J, Fuller F, Balcazar JR, Zeman KL, Duckworth H, Donn KH, O'Riordan TG, Boucher RC, Donaldson SH. Duration of action of hypertonic saline on mucociliary clearance in the normal lung. J Appl Physiol (1985). 2015 Jun 15;118(12):1483-90. doi: 10.1152/japplphysiol.00404.2014. Epub 2015 Apr 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5985C00006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.