Clinical Trials/NCT06664619

NCT06664619

Recruiting

Phase 3

A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma

Teva Branded Pharmaceutical Products R&D LLC227 sites in 1 country724 target enrollmentDecember 12, 2024

InterventionsABS FP Fp/ABS Placebo

DrugsFp/ABS FP ABS Placebo

Overview

Phase: Phase 3
Intervention: ABS
Conditions: Not specified
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Enrollment: 724
Locations: 227
Primary Endpoint: Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
Status: Recruiting
Last Updated: 11 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).

Secondary objectives are:

To evaluate the efficacy of Fp/ABS eMDPI administered four times daily
To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks
To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose

The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

Registry

euclinicaltrials.eu

Start Date

December 12, 2024

End Date

May 31, 2026

Last Updated

11 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Responsible Party

Sponsor

Principal Investigator

Medical Information

Scientific

Teva Branded Pharmaceutical Products R&D Inc.

Eligibility Criteria

Inclusion Criteria

•The participant has a diagnosis of asthma of at least 6 months duration.
•Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication.
•If female, a 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 trial), or is of non-childbearing potential.
•NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

•The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode.
•The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit
•Symptoms of the infection(s) must be completely resolved prior to entering screening.
•The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded.
•The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome.
•NOTE- Additional criteria apply, please contact the investigator for more information

Arms & Interventions

ABS eMDPI

Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)

Intervention: ABS

Fp eMDPI

Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)

Intervention: FP

Fp/ABS eMDPI

Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module

Intervention: Fp/ABS

Placebo eMDPI

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks

Time Frame: Baseline, Week 4

Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.

Change from Baseline trough FEV1 at week 4

Time Frame: Baseline, Week 4

Secondary Outcomes

Time to 15% improvement from baseline FEV1 post-dose on day 1(Baseline to Post-dose on Day 1)
Time to 12% improvement from baseline FEV1 post-dose on day 1(Baseline to Post-dose on Day 1)
Duration of 15% increase in FEV1 from baseline post-dose on day 1(Baseline Pre-dose to Post-dose on Day 1)
Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5(Baseline, Week 4)
Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3(Baseline, Week 4)
Number of participants with at least one treatment-emergent adverse event(Up to Week 4)
Number of participants with at least one treatment-emergent serious adverse event(Up to Week 4)
Number of participants who withdraw from treatment due to an adverse event(Up to Week 4)
Plasma concentration of Fp(Baseline, Week 4)
Plasma concentration of ABS(Baseline, Week 4)