A Phase 3 interventional study of Fp/ABS and FP in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Completed at 189 sites in 13 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
Among 1,694 studies in Asthma with a site in United States — 134 open to participants now, 188 under way, 19 of them phase 3. Asthma · United States.
Among the 1,694 studies in Asthma with a site in United States, this one is the 157th largest by enrollment of the 1,353 interventional ones, is one of 51 that started in 2024, is one of 254 in phase 3, and was the 1,606th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 649 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →134 of the 1,694 studies in Asthma with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,694 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 51 started in 2024.
Median enrollment 100 across the 1,353 interventional studies, 113 across the 329 observational. Of the 1,401 that completed or were terminated, 626 (45%) have results posted.
642 of 1,694 have an industry lead sponsor. The 10 most frequent:
Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Teva Branded Pharmaceutical Products R&D LLC has 2 studies filed under Asthma — fewer than ten, so there is no comparison to draw.
84 of the studies in Asthma with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT06052267Phase 3Teva Branded Pharmaceutical Products R&D LLCA Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations | 2026-12-31 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
Among the 1,694 studies in Asthma with a site in United States, from their registry updates:
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:
The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Drug: Fp/ABS
Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
Drug: FP
Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
Drug: ABS
Drug: Placebo
Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.
Time frame: Baseline, Week 4
Change from Baseline trough FEV1 at week 4
Time frame: Baseline, Week 4
Time to 15% improvement from baseline FEV1 post-dose on day 1
Time frame: Baseline to Post-dose on Day 1
Time to 12% improvement from baseline FEV1 post-dose on day 1
Time frame: Baseline to Post-dose on Day 1
Duration of 15% increase in FEV1 from baseline post-dose on day 1
Time frame: Baseline Pre-dose to Post-dose on Day 1
Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5
The ACQ-6 is a validated 6-item asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ has a possible score ranging from 0 (no impairment) to 6 (maximum impairment), and the total score is the mean of all responses. The total score ranging from 0 (totally controlled) to 6 (severely uncontrolled) with higher scores indicating maximum impairment.
Time frame: Baseline, Week 4
Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3
The Asthma Control Test (ACT) is a participant self-administered tool for identifying those with poorly controlled asthma comprising 5 items, with 4-week recall (on symptoms and daily functioning). It assesses the frequency of shortness of breath and general asthma symptoms, the use of rescue medications, the effect of asthma on daily functioning, and the overall self-assessment of asthma control measured on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Total scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Time frame: Baseline, Week 4
Number of participants with at least one treatment-emergent adverse event
Time frame: Up to Week 4
Number of participants with at least one treatment-emergent serious adverse event
Time frame: Up to Week 4
Number of participants who withdraw from treatment due to an adverse event
Time frame: Up to Week 4
Plasma concentration of Fp
Time frame: Baseline, Week 4
Plasma concentration of ABS
Time frame: Baseline, Week 4
Showing the first 100 of 189 sites across 13 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Oct 2026, 22 months.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 22 months is below that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
Primary completion moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, last on Nov 4, 2026.
Completion moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, last on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Teva Branded Pharmaceutical Products R&D LLC →