A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

Teva Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: FP; Drug: ABS; Drug: Fp/ABS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06664619

2024-517991-39-00 (Registry Identifier)

FpA-AS-30093

Details and patient eligibility

About

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.

Enrollment: 724 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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 1. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

724 participants in 4 patient groups, including a placebo group

Fp/ABS eMDPI

Experimental group

Description:

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

Treatment:

Drug: Fp/ABS

Fp eMDPI

Active Comparator group

Description:

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

Treatment:

Drug: FP

ABS eMDPI

Active Comparator group

Description:

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

Treatment:

Drug: ABS

Placebo eMDPI

Placebo Comparator group

Treatment:

Drug: Placebo