Respiratory
Conditions
Interventions
Sponsors
Teva Branded Pharmaceutical Products R and D LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant is capable of giving signed informed consent. 2. The participant is a female or male 12 years of age or older at the time of informed consent. 3. The participant has a diagnosis of asthma in accordance with NHLBI (2020) or GINA 2023 guidelines of at least 6 months duration. 4. A participant has a pre-bronchodilator FEV1 of =50 to =85% predicted normal for adults and FEV1 of =50 to =90% predicted normal for participants 12 to 17 years of age demonstrated during the screening period. 5. The participant demonstrates age-appropriate spirometry performance during the screening visit 6. Participants must demonstrate at least 15% increase from baseline in FEV1 after treatment with 2 to 4 inhalations of albuterol (salbutamol) HFA 90 mcg per inhalation. 7. The participant demonstrates proper technique using the training inhaler after training at V2 8. The participant is capable of performing PEF measurements using the handheld device 9. Participants currently receive a beta-agonist as rescue medication with or without asthma controller medication. If receiving background asthma therapy, must be on stable maintenance medication for 30 days prior to V1 10. If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant 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
Exclusion criteria
Exclusion criteria: 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. 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. The participant has any recent or planned surgical procedure or history of psychiatric or medical condition 4. The participant is currently being treated with a prohibited medication 5. The participant has cancer not in complete remission for at least 5 years. 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. 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. 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 preceding screening 9. The participant is a current smoker and/or has a history of =10 pack years history of smoking. 10. The participant has significantly abused alcohol and/or prohibited drugs within the previous 24 months in the opinion of the investigator. 11. The participant has known hypersensitivity to any corticosteroid, albuterol, or any of the excipients in the IMP formulations. 12. The participant has another confounding underlying lung disorder 13. The participant has a clinically significant abnormal ECG 14. The participant is an employee or relative of an employee who works at any clinical research center taking part in this trial. 15. More than 1 participant from the same household is excluded 16. Vulnerable participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Fp/ABS eMDPI;To measure the baseline-adjusted post-dose forced expiratory volume in 1 second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr);To measure the baseline-adjusted trough forced expiratory volume in 1 second (FEV1) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Fp/ABS eMDPI administered QID;To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over 4 weeks;To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose | — |
Countries
South Africa
Contacts
Public ContactJan Hendrik Vermeulen
National Principal Investigator
Outcome results
None listed