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Evaluating a new inhaler for asthma treatment in patients 12 and older

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

Phase 3 Interventional Teva Branded Pharmaceutical Products R&D, Inc. · NCT06664619

This study is testing a new inhaler for asthma in people aged 12 and older to see if it works better and is safe compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment724 (estimated)
Ages12 Years and up
SexAll
SponsorTeva Branded Pharmaceutical Products R&D, Inc. Industry-sponsored
Locations163 sites (Phoenix, Arizona and 162 other locations)
Trial IDNCT06664619 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate in participants aged 12 years and older with asthma. The study will involve a randomized, double-blind, placebo-controlled design, where participants will receive either the active inhaler or a placebo four times daily over a period of four weeks. Additionally, the pharmacokinetics of the inhaler will be investigated after a single dose. The total duration of participation for each individual is expected to be around 10 weeks, excluding an optional prescreening visit.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 years and older with a diagnosis of asthma for at least six months who currently use a beta-agonist as a rescue medication.

Not a fit: Patients with a history of life-threatening asthma episodes or recent respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide improved asthma control and relief for patients using the inhaler.

How similar studies have performed: Previous studies have shown positive outcomes with similar inhaler combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 162 other locations

+113 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.