Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler in Patients with Inadequately Controlled Asthma
- Conditions
- Inadequately Controlled AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-002026-24-IT
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 630
1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
2. Participants who have a documented history of physician-diagnosed asthma >= 6 months prior to Visit 1, according to GINA guidelines [GINA, 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to <18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.
3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1.
4. ACQ-7 total score >= 1.5 at Visits 1 and 4.
5. A pre-bronchodilator/pre-dose FEV1 < 90% predicted normal value at Visits 1, 2, and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).
6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of >= 12% and >= 200 mL for participants >= 18 years of age OR a postalbuterol increase of FEV1 of >= 12% for participants 12 to < 18 years of age at Visit 2 or at Visit 3, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.
7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
8. Demonstrate acceptable MDI administration technique.
9. eDiary compliance >= 70% during screening, defined as completing the daily eDiary and answering Yes to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthmarelated syncopal episode(s).
2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
3. Hospitalization for asthma within 8 weeks of Visit 1.
4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
5. Known history of drug or alcohol abuse within 12 months of Visit 1.
6. Use of a nebulizer or a home nebulizer for receiving asthma medications.
7. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
8. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
9. For women only – currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI (superiority) on lung function in participants with inadequately controlled asthma;Secondary Objective: 1. To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI 320 µg (superiority).<br>2. To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI 320 µg sui sintomi e sugli outcome riportati dal paziente;Primary end point(s): 1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks.;Timepoint(s) of evaluation of this end point: Europe(EU) over 24 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. EU (Key secondary): Change from baseline in FEV1 AUC0-3 over 24 Weeks.<br>2. Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks.<br>3. Percentage of responders in ACQ-7 (= 0.5 decrease equals response) over 24 Weeks.<br>4. Percentage of responders in ACQ-5 (= 0.5 decrease equals response) over 24 Weeks.<br>5. Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (= 0.5 increase equals response) over 24 Weeks.<br>6. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1.;Timepoint(s) of evaluation of this end point: Treatment period