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A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT06052267
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:

The primary objective of the study is to demonstrate the efficacy of high dose and low dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).

Secondary Objectives:

To evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS

The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.


Condition or disease Intervention/treatment Phase
Asthma Drug: TEV-56248 Drug: Albuterol sulfate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : July 17, 2026
Estimated Study Completion Date : July 17, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: TEV-56248 Low Dose
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
 Drug: TEV-56248
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Experimental: TEV-56248 High Dose
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
 Drug: TEV-56248
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Active Comparator: Albuterol sulfate
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
 Drug: Albuterol sulfate
Oral inhalation powder


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Severe Clinical Asthma Exacerbation (CAE) [ Time Frame: Up to 35 months ]

Secondary Outcome Measures :
  1. Annualized Severe CAE Rate [ Time Frame: Up to 35 months ]
    Annualized severe CAE rate is calculated for each participant as the sum of total number of CAE events divided by the duration of follow up time (years).

  2. Total Annualized SCS Exposure Over the Treatment Period [ Time Frame: Up to 35 months ]
    Total annualized SCS exposure will be calculated for each participant as the sum of the cumulative doses of SCS divided by the duration of time (years) the participant was in the treatment period, from randomization and up to end of treatment.

  3. Asthma Control Questionnaire-5 (ACQ-5) Response [ Time Frame: Baseline, Week 24 ]

    Response is defined as achieving a decrease in score from baseline value of at least 0.5 (participants aged ≥6 years).

    The ACQ-5 is a shortened version of the validated asthma assessment tool (ie, ACQ) and includes 5 questions that are self-assessments (completed by the participant). Each item on the ACQ-5 has a possible score ranging from 0 to 6, and the total score is the mean of all responses.


  4. Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ) [ Time Frame: Baseline, Week 24 ]

    Responders are defined as the composite of participants achieving an increase in score from baseline of at least 0.5 on the AQLQ+12 or PAQLQ (participants aged ≥7 years).

    The AQLQ + 12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ + 12 is valid for participants aged 12 to 70 years and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Responses are rated on a 7-point scale where 7 = no impairment and 1 = severe impairment.

    The PAQLQ Questionnaire includes 23 items in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). It is intended for participants ages 7-11.


  5. Number of Participants with at Least One Adverse Event [ Time Frame: Up to 35 months ]
    Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), and 12-lead electrocardiogram (ECG) findings.

  6. Number of Participants with at Least One Serious Adverse Event [ Time Frame: Up to 35 months ]
  7. Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events [ Time Frame: Up to 35 months ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
  • The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) within the past 12 months before screening.
  • The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit).
  • If female, the participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the study), or is of nonchildbearing potential

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

  • The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.
  • The participant has a suspected bacterial or viral infection (other than Coronavirus Disease [COVID-19]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.
  • Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19").
  • The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening.
  • The participant is a current tobacco smoker or has a smoking history of ≥10 pack-years, or the participant used tobacco within the past 6 months.
  • The participant has significantly abused alcohol and/or prohibited drugs within the previous 24 months.
  • The participant has participated as a randomized participant in any investigational drug study within 30 days.
  • The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.

NOTE- Additional criteria apply, please contact the investigator for more information

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052267


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT06052267    
Other Study ID Numbers: FpA-AS-30094
2023-505435-12-00 ( Other Identifier: EUCT )
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action