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
- Registration Number
- NCT06664619
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 724
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fp/ABS eMDPI Fp/ABS Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module Fp eMDPI FP Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI) ABS eMDPI ABS Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI) Placebo eMDPI Placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks 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 Baseline, Week 4
- Secondary Outcome Measures
Name Time Method 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 The ACQ-6 is a validated 6-item asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ has a possible score ranging from 0 (no impairment) to 6 (maximum impairment), and the total score is the mean of all responses. The total score ranging from 0 (totally controlled) to 6 (severely uncontrolled) with higher scores indicating maximum impairment.
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 The Asthma Control Test (ACT) is a participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items, with 4-week recall (on symptoms and daily functioning). It assesses the frequency of shortness of breath and general asthma symptoms, the use of rescue medications, the effect of asthma on daily functioning, and the overall self-assessment of asthma control measured on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
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
Trial Locations
- Locations (50)
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 12102
🇺🇸Little Rock, Arkansas, United States
Teva Investigational Site 12103
🇺🇸Huntington Beach, California, United States
Teva Investigational Site 12068
🇺🇸La Palma, California, United States
Teva Investigational Site 12088
🇺🇸Los Angeles, California, United States
Teva Investigational Site 12094
🇺🇸Los Angeles, 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 12070
🇺🇸Vista, California, United States
Teva Investigational Site 12091
🇺🇸Walnut Creek, California, United States
Teva Investigational Site 12142
🇺🇸Lakewood, Colorado, United States
Teva Investigational Site 12098
🇺🇸Lake City, Florida, United States
Teva Investigational Site 12118
🇺🇸Lake Worth, Florida, United States
Teva Investigational Site 12079
🇺🇸Melbourne, Florida, United States
Teva Investigational Site 12092
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 12071
🇺🇸Miami, Florida, United States
Teva Investigational Site 12074
🇺🇸Miami, Florida, United States
Teva Investigational Site 12086
🇺🇸Miami, Florida, United States
Teva Investigational Site 12061
🇺🇸Miami, Florida, United States
Teva Investigational Site 12097
🇺🇸Miami, Florida, United States
Teva Investigational Site 12076
🇺🇸North Miami Beach, Florida, United States
Teva Investigational Site 12095
🇺🇸Palmetto Bay, Florida, United States
Teva Investigational Site 12075
🇺🇸Pompano Beach, Florida, United States
Teva Investigational Site 12078
🇺🇸Tampa, Florida, United States
Teva Investigational Site 12081
🇺🇸Nottingham, Maryland, United States
Teva Investigational Site 12073
🇺🇸Minneapolis, Minnesota, United States
Teva Investigational Site 12066
🇺🇸Richfield, Minnesota, United States
Teva Investigational Site 12089
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 12110
🇺🇸Jersey City, New Jersey, United States
Teva Investigational Site 12115
🇺🇸Charlotte, North Carolina, United States
Teva Investigational Site 12085
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 12063
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 12072
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 12114
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12067
🇺🇸Columbia, South Carolina, United States
Teva Investigational Site 12112
🇺🇸North Charleston, South Carolina, United States
Teva Investigational Site 12107
🇺🇸Rock Hill, South Carolina, United States
Teva Investigational Site 12083
🇺🇸Austin, Texas, United States
Teva Investigational Site 12060
🇺🇸Austin, Texas, United States
Teva Investigational Site 12077
🇺🇸Corsicana, Texas, United States
Teva Investigational Site 12090
🇺🇸Dallas, Texas, United States
Teva Investigational Site 12143
🇺🇸El Paso, Texas, United States
Teva Investigational Site 12080
🇺🇸Kingwood, Texas, United States
Teva Investigational Site 12084
🇺🇸Victoria, Texas, United States
Teva Investigational Site 12082
🇺🇸Salt Lake City, Utah, United States
Teva Investigational Site 12093
🇺🇸Portsmouth, Virginia, United States
Teva Investigational Site 12062
🇺🇸Greenfield, Wisconsin, United States