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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

22 Jul 2025 → ongoing

Decision date (initial)

2025-06-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Teva Branded Pharmaceutical Products R&D LLC

External identifiers

EU CT number

2024-517991-39-00

ClinicalTrials.gov

NCT06664619

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Safety, Efficacy

To evaluate the efficacy of Fp/ABS eMDPI

Secondary objectives 3

1. To evaluate the efficacy of Fp/ABS eMDPI administered QID
2. To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over 4 weeks
3. To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose

Conditions and MedDRA coding

Asthma

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

n/a

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. The participant is capable of giving signed informed consent (≥18 years of age). Participants 12 to 17 years of age (or as applicable per local requirements) are able to provide assent and written consent must be provided by a parent/legally acceptable representative before any trial procedures are performed.
2. 2. The participant is a female or male 12 years of age or older at the time of informed consent or as allowed by local regulation.
3. 3. The participant has a diagnosis of asthma in accordance with NHLBI (2020) or GINA 2023 guidelines of at least 6 months duration.
4. 4. Lung Function: A participant has a pre-bronchodilator FEV1 of ≥50 to ≤85% predicted normal for adults (≥18 years of age) and FEV1 of ≥50 to ≤90% predicted normal for participants 12 to 17 years of age demonstrated during the screening period
5. 5. The participant demonstrates age-appropriate spirometry performance during the screening visit (V1) (ie, meets the American Thoracic Society/European Respiratory Society acceptability/repeatability criteria
6. 6. Response to bronchodilator testing (Reversibility): Participants must demonstrate at least 15% change (ie, increase) from baseline in FEV1 after treatment with 2 to 4 inhalations of albuterol (salbutamol) HFA 90 mcg per inhalation. Participants aged ≥18 years must also demonstrate at least 200 mL increase from baseline FEV1. Reversibility testing may be repeated once during the screening period to qualify for the trial as needed for this inclusion criterion.
7. 7. The participant demonstrates proper technique using the training inhaler after training at V2 (beginning of the run-in period).
8. 8. The participant is capable of performing PEF measurements using the handheld device, as judged by the investigator, at V2.
9. 9. Participants currently receive a beta-agonist (eg, salbutamol [albuterol] or ICS-albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication. Participants that are receiving background asthma controller therapy must be on stable maintenance medication for 30 days prior to V1 without change to dose or frequency of therapy. Acceptable maintenance therapy prior to V1 includes non-corticosteroid therapy (leukotriene antagonists or theophylline), low or moderate dose of ICS with or without LABA. The participant should be deemed capable of transitioning off these medications for the run-in period by judgement of the investigator.
10. 10. 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 or, if of childbearing potential, has a negative serum β-human chorionic gonadotropin (β-HCG) test at screening visit (V2) and is willing to commit to using a medically accepted, highly effective method of birth control.
11. 11. The participant must be willing and able to comply with trial restrictions and to remain at the investigational center for the required duration during the trial period, and willing to return to the investigational center for further visits, as applicable, and the follow-up procedures and assessments as specified in this protocol.

Exclusion criteria 16

1. 1. 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.
2. 2. The participant has experienced an asthma exacerbation requiring treatment with systemic corticosteroids within 3 months prior to the screening visit or has had a hospitalization for asthma lasting greater than 24 hours in the preceding 6 months.
3. 3. The participant has any recent or planned surgical procedure or history of psychiatric or medical condition including clinically significant congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease or cardiac dysrhythmia that, in the opinion of the investigator, could jeopardize or would compromise the participant’s ability to participate in this trial or compromise the interpretation of the trial measures and endpoints.
4. 4. The participant is currently being treated with a prohibited medication or has been treated with a prohibited medication within the washout periods.
5. 5. The participant has cancer not in complete remission for at least 5 years. Note: Participants with fully resected basal cell or squamous cell carcinoma of the skin, localized prostate cancer or carcinoma in situ of the cervix may be included if the investigator believes the condition has been clinically controlled and would not represent a safety concern.
6. 6. The participant has previously participated in this trial as a randomized participant or previously participated in a trial with TEV-56248 as IMP treatment.
7. 7. 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 V1. Symptoms of the infection(s) must be completely resolved prior to entering screening.
8. 8. The participant has participated as a randomized participant in any investigational drug trial within 30 days or within 5 half-lives of the IMP under trial (if treated) preceding screening (whichever is longer) or plans to participate in another investigational drug or device trial at any time during this trial. Note: Prior depemokimab exposure is prohibited without exception.
9. 9. 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.
10. 10. The participant has significantly abused alcohol and/or prohibited drugs within the previous 24 months in the opinion of the investigator. Note: a positive drug screen without medical explanation will preclude participant from being included in the trial.
11. 11. The participant has known hypersensitivity to any corticosteroid, albuterol (salbutamol), or any of the excipients (ie, lactose) in the IMP formulations. Note: dietary lactose intolerance does not exclude the participant from participation in the trial or as per the investigator’s medical decision.
12. 12. 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.
13. 13. The participant has a clinically significant abnormal ECG.
14. 14. The participant is an employee or relative of an employee who works at any clinical research center taking part in this trial.
15. 15. More than 1 participant from the same household is excluded unless the first participant completes the trial and has returned IMP. Then, the second household member may be screened and included, as applicable.
16. 16. Vulnerable participants (eg, people kept in detention).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Baseline-adjusted post-dose forced expiratory volume in one second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr) over 4 weeks (FEV1 AUEC0-6hr)
2. Baseline-adjusted trough FEV1at week 4

Secondary endpoints 9

1. Time to 15% improvement from baseline FEV1 post-dose on day 1.
2. Time to 12% improvement from baseline FEV1 post-dose on day 1.
3. Duration of 15% increase in FEV1 from baseline post-dose on day 1
4. 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
5. Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3
6. Occurrence of adverse events during the trial.
7. Occurrence of serious adverse events during the trial.
8. Treatment withdrawal due to treatment-emergent adverse events.
9. Plasma concentration of Fp and ABS at the specified timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Teva Branded Pharmaceutical Products R&D LLC

Sponsor organisation

Teva Branded Pharmaceutical Products R&D LLC

Address

145 Brandywine Parkway

City

West Chester

Postcode

19380-4245

Country

United States

Scientific contact point

Organisation

Teva Branded Pharmaceutical Products R&D LLC

Contact name

Medical Information

Public contact point

Organisation

Teva Branded Pharmaceutical Products R&D LLC

Contact name

Medical Information

Third parties 11

Locations

6 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 134 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

16 submissions — initial application plus substantial / non-substantial modifications