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Clinical Trials in Turkey / NCT06664619
Recruiting Phase 3

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

NCT06664619 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 3
Started
2024-12-12
Last updated
2026-08-31

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Fp/ABSFPABSPlacebo

Fp/ABS: Inhalation powder

FP: Inhalation powder

ABS: Inhalation powder

Placebo: Inhalation powder

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (189)

FacilityCityRegionStatus
Teva Investigational Site 12087 Phoenix Arizona Recruiting
Teva Investigational Site 12144 Phoenix Arizona Completed
Teva Investigational Site 12104 Tucson Arizona Completed
Teva Investigational Site 12146 Tucson Arizona Recruiting
Teva Investigational Site 12102 Little Rock Arkansas Recruiting
Teva Investigational Site 12154 Encinitas California Recruiting
Teva Investigational Site 12103 Huntington Beach California Recruiting
Teva Investigational Site 12068 La Palma California Recruiting
Teva Investigational Site 12152 Laguna Niguel California Recruiting
Teva Investigational Site 12145 Long Beach California Recruiting
Teva Investigational Site 12088 Los Angeles California Recruiting
Teva Investigational Site 12094 Los Angeles California Recruiting
Teva Investigational Site 12161 Northridge California Recruiting
Teva Investigational Site 12105 Oxnard California Recruiting
Teva Investigational Site 12101 Sacramento California Completed
Teva Investigational Site 12064 San Jose California Recruiting
Teva Investigational Site 12109 Upland California Completed
Teva Investigational Site 12070 Vista California Completed
Teva Investigational Site 12091 Walnut Creek California Completed
Teva Investigational Site 12142 Lakewood Colorado Recruiting
Teva Investigational Site 12098 Lake City Florida Completed
Teva Investigational Site 12118 Lake Worth Florida Completed
Teva Investigational Site 12079 Melbourne Florida Recruiting
Teva Investigational Site 12071 Miami Florida Recruiting
Teva Investigational Site 12074 Miami Florida Recruiting
Teva Investigational Site 12086 Miami Florida Recruiting
Teva Investigational Site 12061 Miami Florida Completed
Teva Investigational Site 12097 Miami Florida Recruiting
Teva Investigational Site 12092 Miami Lakes Florida Completed
Teva Investigational Site 12076 North Miami Beach Florida Completed
Teva Investigational Site 12095 Palmetto Bay Florida Completed
Teva Investigational Site 12075 Pompano Beach Florida Recruiting
Teva Investigational Site 12078 Tampa Florida Recruiting
Teva Investigational Site 12175 Conyers Georgia Recruiting
Teva Investigational Site 12156 Boise Idaho Recruiting
Teva Investigational Site 12162 Westchester Illinois Recruiting
Teva Investigational Site 12169 Shreveport Louisiana Recruiting
Teva Investigational Site 12081 Nottingham Maryland Completed
Teva Investigational Site 12106 Towson Maryland Recruiting
Teva Investigational Site 12157 White Marsh Maryland Recruiting

+ 149 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664619 on ClinicalTrials.gov ↗ ← All trials in Turkey