Clinical trial NCT06664619: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 724
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
timeFrame: Baseline, Week 4
measure: Change from Baseline trough FEV1 at week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Time to 15% improvement from baseline FEV1 post-dose on day 1
timeFrame: Baseline to Post-dose on Day 1
measure: Time to 12% improvement from baseline FEV1 post-dose on day 1
timeFrame: Baseline to Post-dose on Day 1
measure: Duration of 15% increase in FEV1 from baseline post-dose on day 1
timeFrame: Baseline Pre-dose to Post-dose on Day 1
measure: 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
timeFrame: Baseline, Week 4
measure: Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3
timeFrame: Baseline, Week 4
measure: Number of participants with at least one treatment-emergent adverse event
timeFrame: Up to Week 4
measure: Number of participants with at least one treatment-emergent serious adverse event
timeFrame: Up to Week 4
measure: Number of participants who withdraw from treatment due to an adverse event
timeFrame: Up to Week 4
measure: Plasma concentration of Fp
timeFrame: Baseline, Week 4
measure: Plasma concentration of ABS
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 12087
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 12144
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 12104
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 12102
state: Arkansas
city: Huntington Beach
country: United States
facility: Teva Investigational Site 12103
state: California
city: La Palma
country: United States
facility: Teva Investigational Site 12068
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 12088
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 12094
state: California
city: Oxnard
country: United States
facility: Teva Investigational Site 12105
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 12101
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 12064
state: California
city: Upland
country: United States
facility: Teva Investigational Site 12109
state: California
city: Vista
country: United States
facility: Teva Investigational Site 12070
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 12091
state: California
city: Lakewood
country: United States
facility: Teva Investigational Site 12142
state: Colorado
city: Lake City
country: United States
facility: Teva Investigational Site 12098
state: Florida
city: Lake Worth
country: United States
facility: Teva Investigational Site 12118
state: Florida
city: Melbourne
country: United States
facility: Teva Investigational Site 12079
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 12092
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12071
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12074
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12086
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12061
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12097
state: Florida
city: North Miami Beach
country: United States
facility: Teva Investigational Site 12076
state: Florida
city: Palmetto Bay
country: United States
facility: Teva Investigational Site 12095
state: Florida
city: Pompano Beach
country: United States
facility: Teva Investigational Site 12075
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 12078
state: Florida
city: Nottingham
country: United States
facility: Teva Investigational Site 12081
state: Maryland
city: Towson
country: United States
facility: Teva Investigational Site 12106
state: Maryland
city: Minneapolis
country: United States
facility: Teva Investigational Site 12073
state: Minnesota
city: Richfield
country: United States
facility: Teva Investigational Site 12066
state: Minnesota
city: Saint Louis
country: United States
facility: Teva Investigational Site 12089
state: Missouri
city: Jersey City
country: United States
facility: Teva Investigational Site 12110
state: New Jersey
city: Charlotte
country: United States
facility: Teva Investigational Site 12115
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 12085
state: North Carolina
city: Toledo
country: United States
facility: Teva Investigational Site 12063
state: Ohio
city: Clackamas
country: United States
facility: Teva Investigational Site 12117
state: Oregon
city: Philadelphia
country: United States
facility: Teva Investigational Site 12072
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 12114
state: Pennsylvania
city: Columbia
country: United States
facility: Teva Investigational Site 12067
state: South Carolina
city: Myrtle Beach
country: United States
facility: Teva Investigational Site 12111
state: South Carolina
city: North Charleston
country: United States
facility: Teva Investigational Site 12112
state: South Carolina
city: Rock Hill
country: United States
facility: Teva Investigational Site 12107
state: South Carolina
city: Austin
country: United States
facility: Teva Investigational Site 12083
state: Texas
city: Austin
country: United States
facility: Teva Investigational Site 12060
state: Texas
city: Corsicana
country: United States
facility: Teva Investigational Site 12077
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 12090
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 12143
state: Texas
city: Kingwood
country: United States
facility: Teva Investigational Site 12080
state: Texas
city: Victoria
country: United States
facility: Teva Investigational Site 12084
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 12082
state: Utah
city: Portsmouth
country: United States
facility: Teva Investigational Site 12093
state: Virginia
city: Greenfield
country: United States
facility: Teva Investigational Site 12062
state: Wisconsin
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: