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Phase 3 Completed N=52 Randomized Quadruple-blind Treatment

Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma

Source: ClinicalTrials.gov NCT05850494 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose — 2.969; 2.970; 2.955; 2.965 Litres
◆ Published Evidence
Highly cited
15,667citations · ~746 / year
Standardisation of spirometry.
The European respiratory journal · 2005 · Open access · High-confidence link

Summary

A study to assess bronchospasm potentially induced by HFO MDI as compared with HFA MDI in participants with well controlled or partially controlled asthma

Linked Publications (5)

  • Standardisation of spirometry.
    The European respiratory journal · 2005 · 15,667 citations · Open access · High-confidence link
  • Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement.
    American journal of respiratory and critical care medicine · 2019 · 4,074 citations · Open access · High-confidence link
  • Development and validation of a questionnaire to measure asthma control.
    The European respiratory journal · 1999 · 2,499 citations · Open access · High-confidence link
  • Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire.
    Respiratory medicine · 2006 · 1,009 citations · High-confidence link
  • A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma.
    Pulmonary pharmacology & therapeutics · 2020 · 16 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 15 Minutes (AUC0-15 Min) Post-dose
2.969; 2.970; 2.955; 2.965; -0.014; -0.004
SECONDARY
Number of Participants With Bronchospasm Events
0; 0
SECONDARY
Safety and Tolerability Evaluated in Terms of Adverse Events (AEs)
2; 4; 0; 0; 0; 0

Eligibility Criteria

Inclusion Criteria

  • Age
  • Male and female participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent form (ICF).

Type of Participant and Disease Characteristics

  • Participants who have a documented history of physician-diagnosed asthma

≥ 12 months prior to Visit 1, according to GINA guidelines (GINA 2022).

  • Participants who are well controlled or partially controlled on their current treatment for asthma, including, low-dose ICS daily or low-dose ICS/formoterol as needed (not approved in the US), or SABA as needed, or low-dose ICS whenever SABA as needed is used (low-dose ICS as defined by GINA 2022 in Table 4), for 4 weeks prior to screening.
  • ACQ-5 total score 60% predicted normal value at Visit 1.
  • Demonstrate acceptable MDI administration technique.

Sex and Contraceptive/Barrier Requirements

  • Females must be not of childbearing potential, or should be using a form of highly effective birth control as defined below:
  • Female participants 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 included in this study will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range.
  • 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 enrolment, 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 amenorrhoea 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.

  • 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). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception.
  • Contraceptive subdermal implant
  • Intrauterine device or intrauterine system
  • Oral contraceptive (combined or progesterone only)
  • Injectable progestogen
  • Contraceptive vaginal ring
  • Percutaneous contraceptive patches
  • Male partner sterilization 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.
  • Bilateral tubal ligation Informed Consent 8 Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria

  • Medical Conditions
  • Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05850494) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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