A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort-R Turbuhaler-R in Participants with Inadequately Controlled Asthma

JRCT ID: jRCT2031210576

Registered date:23/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 18/02/2022
• Target sample size: 138
• Countries of recruitment: Canada,Japan,Germany,Japan,Italy,Japan,Spain,Japan,United States of America,Japan
• Study type: Interventional
• Intervention(s): BFF MDI 320/9.6 microgram, BFF MDI 160/9.6 microgram, BD MDI 320 microgram, Open-label Symbicort-R Turbuhaler-R

Outcome(s)

Primary Outcome

Change from baseline in morning pre-dose trough FEV1 over 12 to 24 Weeks
Change from baseline in morning pre-dose trough FEV1 over 12 to 24 Weeks

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. 12 to 80 years of age, male and female, BMI less 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 or more 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 (age 12 years or more and below18 years) 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 or more at Visits 1 and 4.
5. Pre-bronchodilator/pre-dose FEV1 less than 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% or more and 200 mL1 or more for participants 18 years or more of age OR a post-albuterol increase of FEV1 of 12% or more for participants 12 or more and below 18 years of age, 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% or more 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.

Exclude criteria

1.Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related 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 over 10 pack-years history, or former smokers who stopped smoking below 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.

Related Information

• Primary Sponsor: Ageshi Yuji