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
Phase 3
Interventional Study
Asthma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 724 (estimated)
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC · Industry
Who this trial is looking for
This trial is looking for people aged 12 and older who have been diagnosed with asthma for at least six months and currently use a quick-relief inhaler. However, it cannot include anyone who has had serious asthma attacks, recent respiratory infections, or other serious lung problems. If you're a current smoker or have recently smoked, you wouldn't be able to participate either.
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About This Trial
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…
Trial Locations
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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 particip…
Contacts