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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Fp/ABS

Inhalation powder

DRUG

FP

Inhalation powder

DRUG

ABS

Inhalation powder

DRUG

Placebo

Inhalation powder

Locations (20)

Teva Investigational Site 12087
Phoenix, Arizona, United States
Teva Investigational Site 12144
Phoenix, Arizona, United States
Teva Investigational Site 12104
Tucson, Arizona, United States
Teva Investigational Site 12146
Tucson, Arizona, United States
Teva Investigational Site 12102
Little Rock, Arkansas, United States
Teva Investigational Site 12154
Encinitas, California, United States
Teva Investigational Site 12103
Huntington Beach, California, United States
Teva Investigational Site 12068
La Palma, California, United States
Teva Investigational Site 12152
Laguna Niguel, California, United States
Teva Investigational Site 12145
Long Beach, California, United States
Teva Investigational Site 12088
Los Angeles, California, United States
Teva Investigational Site 12094
Los Angeles, California, United States
Teva Investigational Site 12161
Northridge, California, United States
Teva Investigational Site 12105
Oxnard, California, United States
Teva Investigational Site 12101
Sacramento, California, United States
Teva Investigational Site 12064
San Jose, California, United States
Teva Investigational Site 12109
Upland, California, United States
Teva Investigational Site 12070
Vista, California, United States
Teva Investigational Site 12091
Walnut Creek, California, United States
Teva Investigational Site 12142
Lakewood, Colorado, United States