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
| NCT ID | NCT06664619 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Teva Branded Pharmaceutical Products R&D LLC |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 724 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2026-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 724 participants in total. It began in 2024-12-12 with a primary completion date of 2026-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Teva Medical Expert, MD
STUDY DIRECTOR
Teva Branded Pharmaceutical Products R&D LLC
Frequently Asked Questions
Who can join the NCT06664619 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06664619 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 724 participants.
Is NCT06664619 currently recruiting?
Yes, NCT06664619 is actively recruiting participants. Contact the research team at USMedInfo@tevapharm.com for enrollment information.
Where is the NCT06664619 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, Tucson, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06664619 clinical trial?
NCT06664619 is sponsored by Teva Branded Pharmaceutical Products R&D LLC. The principal investigator is Teva Medical Expert, MD at Teva Branded Pharmaceutical Products R&D LLC. The trial plans to enroll 724 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.