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
Recruiting · NCT06664619 · Interventional (participants receive a specific treatment) · Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC
View the official record on ClinicalTrials.gov →Interventions studied
ABSFPFp/ABSPlacebo
What this trial is 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.
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 27 US states.
- 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
- 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 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 12092 - Miami Lakes, 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 12175 - Conyers, Georgia, United States
- Teva Investigational Site 12156 - Boise, Idaho, United States
- Teva Investigational Site 12162 - Westchester, Illinois, United States
- Teva Investigational Site 12169 - Shreveport, Louisiana, United States
- Teva Investigational Site 12081 - Nottingham, Maryland, United States
- Teva Investigational Site 12106 - Towson, Maryland, United States
- Teva Investigational Site 12157 - White Marsh, Maryland, United States
- Teva Investigational Site 12119 - Boston, Massachusetts, United States
- Teva Investigational Site 12182 - South Dartmouth, Massachusetts, United States
- Teva Investigational Site 12187 - Brighton, Michigan, United States
- Teva Investigational Site 12073 - Minneapolis, Minnesota, United States
- Teva Investigational Site 12066 - Richfield, Minnesota, United States
- Teva Investigational Site 12149 - Columbia, Missouri, United States
- Teva Investigational Site 12108 - St Louis, Missouri, United States
- Teva Investigational Site 12089 - St Louis, Missouri, United States
- Teva Investigational Site 12158 - Hastings, Nebraska, United States
- Teva Investigational Site 12160 - Las Vegas, Nevada, United States
- Teva Investigational Site 12150 - Las Vegas, Nevada, United States
- Teva Investigational Site 12110 - Jersey City, New Jersey, United States
- Teva Investigational Site 12115 - Charlotte, North Carolina, United States
- Teva Investigational Site 12185 - High Point, North Carolina, United States
- Teva Investigational Site 12085 - Raleigh, North Carolina, United States
- Teva Investigational Site 12063 - Toledo, Ohio, United States
- Teva Investigational Site 12178 - Oklahoma City, Oklahoma, United States
- Teva Investigational Site 12155 - Tulsa, Oklahoma, United States
- Teva Investigational Site 12170 - Tulsa, Oklahoma, United States
- Teva Investigational Site 12117 - Clackamas, Oregon, United States
Showing 60 of 189 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →