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Bronchodilator
Fluticasone + Albuterol for Asthma
Phase 3
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights
Study Summary
This trial tests a new inhaler for asthma that is expected to reduce severe attacks while also minimizing steroid use.
Who is the study for?
This trial is for asthma patients with a history of severe exacerbations in the past year, using stable asthma medication for at least a month. It's not for pregnant women or those trying to conceive, recent participants in other drug studies, heavy drinkers/drug users, current/recent smokers, people with life-threatening asthma history or psychiatric hospitalizations.Check my eligibility
What is being tested?
The study tests high and low doses of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) via an inhaler against Albuterol Sulfate alone to prevent severe asthma attacks. Participants will be observed for at least 28 weeks to assess efficacy and safety.See study design
What are the potential side effects?
Potential side effects may include irritation in the throat or mouth, headaches, shaking hands (tremors), fast heart rate (palpitations), muscle cramps, coughing and nervousness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma for at least a year.
Select...
I have been diagnosed with asthma for at least a year.
Select...
I have had a severe asthma attack in the last year.
Select...
I have had a severe asthma attack in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Severe Clinical Asthma Exacerbation (CAE)
Secondary outcome measures
Annualized Severe CAE Rate
Asthma Control Questionnaire-5 (ACQ-5) Response
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
+4 moreSide effects data
From 2014 Phase 4 trial • 152 Patients • NCT019222712%
Nasopharyngitis
1%
Hypercholesterolaemia
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Condition aggravated
1%
Urinary tract infection
1%
Excoriation
1%
Headache
1%
Chronic obstructive pulmonary disease
1%
Cough
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
NVA237
Tiotropium
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TEV-56248 Low DoseExperimental Treatment1 Intervention
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Group II: TEV-56248 High DoseExperimental Treatment1 Intervention
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Group III: Albuterol sulfateActive Control1 Intervention
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,483,180 Total Patients Enrolled
63 Trials studying Asthma
2,614,015 Patients Enrolled for Asthma
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
36,583 Total Patients Enrolled
22 Trials studying Asthma
10,444 Patients Enrolled for Asthma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of safety measures are in place for TEV-56248 Low Dose?
"The safety of TEV-56248 Low Dose has been assessed and given a score of 3 due to the amount of research backing its efficacy, as well as multiple studies confirming its security."
Answered by AI
Has enrollment begun for this research endeavor?
"This medical trial, which was originally launched on August 30th 2023, is still recruiting patients. The most recent changes to the study were uploaded September 18th 2023 according to clinicaltrials.gov."
Answered by AI
What is the current enrollment for this clinical experimentation?
"Affirmative. According to clinicaltrials.gov, this medical investigation is presently recruiting patients. The trial was first advertised on August 30th 2023 and had its last edit made September 18th of the same year. A total 2196 volunteers are needed at one site for this experiment's completion."
Answered by AI
Who else is applying?
What site did they apply to?
Teva Investigational Site 15611
Teva Investigational Site 15593
Teva Investigational Site 15607
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
See if there is anything better for me to take. I've had asthma my whole life and it's never been completely under control so I'm open to trying something new.
PatientReceived 1 prior treatment
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