FLUTICASONE PROPIONATE, SALBUTAMOL SULFATE for Asthma

Inclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- 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.\n- 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.\n- 3. The participant has a diagnosis of asthma in accordance with NHLBI (2020) or GINA 2023 guidelines of at least 6 months duration.\n- 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\n- 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\n- 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.\n- 7. The participant demonstrates proper technique using the training inhaler after training at V2 (beginning of the run-in period).\n- 8. The participant is capable of performing PEF measurements using the handheld device, as judged by the investigator, at V2.\n- 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."}

Exclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- 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.\n- 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.\n- 13. The participant has a clinically significant abnormal ECG.\n- 14. The participant is an employee or relative of an employee who works at any clinical research center taking part in this trial.\n- 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.\n- 16. Vulnerable participants (eg, people kept in detention).\n- 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.\n- 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.\n- 4. The participant is currently being treated with a prohibited medication or has been treated with a prohibited medication within the washout periods.\n- 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.\n- 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.\n- 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.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Area under the effect curve (AUEC) for post-dose FEV1 from time 0 to 6 hours, adjusted for baseline, measured over the 4-week treatment period."}
• {"endpoint_text":"- Baseline-adjusted trough FEV1at week 4","definition_or_measurement_approach":"Trough FEV1 measured at week 4 (pre-dose), adjusted for baseline FEV1."}

Secondary endpoints

• {"endpoint_text":"- Time to 15% improvement from baseline FEV1 post-dose on day 1.","definition_or_measurement_approach":"Time from dose to achievement of ≥15% increase in FEV1 from baseline on Day 1."}
• {"endpoint_text":"- Time to 12% improvement from baseline FEV1 post-dose on day 1.","definition_or_measurement_approach":"Time from dose to achievement of ≥12% increase in FEV1 from baseline on Day 1."}
• {"endpoint_text":"- Duration of 15% increase in FEV1 from baseline post-dose on day 1","definition_or_measurement_approach":"Duration (time) that FEV1 remains at least 15% above baseline after dosing on Day 1."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Responder defined as ≥0.5 decrease in ACQ-6 score from baseline at Week 4 for participants with baseline ACQ-6 ≥1.5."}
• {"endpoint_text":"- Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3","definition_or_measurement_approach":"Responder defined as ≥3 point increase in ACT score from baseline at Week 4."}
• {"endpoint_text":"- Occurrence of adverse events during the trial.","definition_or_measurement_approach":"Recording and reporting of all adverse events during the trial per safety reporting procedures."}
• {"endpoint_text":"- Occurrence of serious adverse events during the trial.","definition_or_measurement_approach":"Recording and reporting of serious adverse events during the trial per safety reporting procedures."}
• {"endpoint_text":"- Treatment withdrawal due to treatment-emergent adverse events.","definition_or_measurement_approach":"Number and details of participants withdrawing from treatment due to treatment-emergent AEs."}
• {"endpoint_text":"- Plasma concentration of Fp and ABS at the specified timepoints","definition_or_measurement_approach":"Pharmacokinetic measurements of plasma concentrations of fluticasone propionate (Fp) and albuterol sulfate (ABS) at pre-specified timepoints."}

Methods

• Flyer: printed recruitment flyers (documents K2_*_Flyer_* present) intended for potential participants/patients; country-specific flyers available (documents exist for RO, SVK, DE, PL, BG, CZ).
• Poster: recruitment posters (documents K2_*_Poster_* present) for clinic/public display; country-specific posters available (RO, SVK, DE, PL, BG, CZ).
• Dr-to-Patient Letter: letters from physicians to patients (documents K2_*_Dr-to-Patient-Letter_* present) used to inform eligible patients; country-specific versions available (RO, SVK, DE, PL, BG, CZ).
• Dr-to-Dr Letter: communications to referring physicians (documents K2_*_Dr-to-Dr-Letter_* present) to support site referral recruitment; country-specific versions available.
• Appointment Card: clinic appointment cards for screened/consented participants (documents K2_*_Appointment-Card_* present) — country-specific.
• FlipChart / FlipChart materials: educational/engagement flipcharts for site staff to use during outreach (documents K2_*_FlipChart_* present) — country-specific.
• Recruitment Brochure / Welcome Guide: informational brochures and welcome guides for participants (documents K2_*_Recruitment-Brochure_*, K2_*_Welcome-Guide_* present) — country-specific.
• Vision-Engage-App: a digital app referenced (document K2_Vision-Engage-App_DEU_DEU) as part of recruitment/engagement in Germany.
• Elligo / direct-to-patient support: Elligo Health Research listed among third parties with duties including reimbursement/stipend distribution, supporting direct-to-patient activities (documented in sponsor third parties).

Germany

Earliest CTIS Part Ii Submission Date

16-05-2025

Latest Decision Or Authorization Date

12-12-2025

Processing Time Days

210

Number Of Sites

12

Number Of Participants

148

Czechia

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

366

Number Of Sites

7

Number Of Participants

82

Poland

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

324

Number Of Sites

9

Number Of Participants

48

Romania

Earliest CTIS Part Ii Submission Date

12-05-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

245

Number Of Sites

3

Number Of Participants

72

Bulgaria

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

359

Number Of Sites

13

Number Of Participants

131

Primary sponsor

Full Name

Teva Branded Pharmaceutical Products R&D LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

Safety reporting to EC/IRBs; medical writing limited to ICFs; site contracting; vendor management (Central Labs, Medidata EDC, Elligo) per sponsorDuties.

Name

Perceptive Eclinical Limited / Perceptive Informatics Inc.

Responsibilities

Randomization, Trial and Supply Management.

Name

eResearchTechnology GmbH

Responsibilities

Central reader services for respiratory & cardiac devices (ECG/Spirometry) and eCOA support.

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Safety Reporting to EC/IRBs; Medical Writing - limited to ICFs only; Site contracting; Vendor management: Central Labs, Medidata EDC, Elligo - Pat. reimbursement (sponsorDuties entries present)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Supporting clinical trial sponsors in the collection of electronic clinical outcome assessments (eCOA).","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Safety Labs, PK sample storage; additional listed duties in sponsorDuties.","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Central Reader - Respiratory & Cardiac Devices – ECG/Spirometry.","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Randomization Trial and Supply management.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Randomisation and Trial Supply Management.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Elligo Health Research Inc.","duties_or_roles":"Reimbursement and stipend distribution.","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Investigator Meeting Services.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Main depot for the study.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Support duties (sponsorDuties code 7 listed).","organisation_type":"Non-Pharmaceutical company"}
• {"country":"India","full_name":"Watson Pharma Private Limited","duties_or_roles":"Pharmacokinetic sample analysis.","organisation_type":"Pharmaceutical company"}