Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant … (NCT05850494) | Clinical Trial Compass
CompletedPhase 3
Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma
United States52 participantsStarted 2023-05-02
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent form (ICF).
✓. Participants who have a documented history of physician-diagnosed asthma
✓. 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 \< 1.5 at Visit 1.
✓. A pre-bronchodilator FEV1 \> 60% predicted normal value at Visit 1.
✓. Females must be not of childbearing potential, or should be using a form of highly effective birth control as defined below:
Exclusion criteria
✕. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
✕. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
✕. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (e.g., active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, COPD, and uncontrolled severe asthma). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or that could affect the safety/tolerability analysis.
What they're measuring
1
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
Timeframe: 30 minutes prior to dosing and at 5, 15, and 30 minutes post-dose
✕. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the screening period.
✕. Hospitalization for asthma within 1 year prior to Visit 1.
✕. Admission to intensive care unit or mechanical ventilation due to asthma exacerbation.
✕. Known history of drug or alcohol abuse within 12 months of Visit 1.
✕. Do not meet the stable dosing period prior to Visit 1 (see Table 5) or unable to abstain from protocol-defined prohibited medications during screening and treatment periods (see Table 6 and Table 7).