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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04609904
Other study ID # D5982C00008
Secondary ID 2023-505786-8820
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2021
Est. completion date March 21, 2025

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.


Description:

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BGF MDI 320/28.8/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BGF MDI 320/14.4/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BFF MDI 320/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler
BFF pMDI 320/9 µg
Budesonide/formoterol fumarate pressurized metered dose inhaler

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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  China,  Colombia,  Costa Rica,  Czechia,  Germany,  Greece,  Israel,  Mexico,  Portugal,  Puerto Rico,  Russian Federation,  Saudi Arabia,  Slovakia,  South Africa,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 24 Weeks
Primary Rate of severe asthma exacerbations Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Rate of severe asthma exacerbations
Up to 52 Weeks
Secondary Change from baseline in morning pre-dose trough FEV1 at Week 24 Change from baseline in morning pre-dose trough FEV1 at Week 24 24 Weeks
Secondary Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (=0.5 decrease equals response) at Week 24 Percentage of responders in ACQ-7 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 24 Weeks
Secondary Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24 Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 24 Weeks
Secondary Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (=0.5 increase equals response) at Week 24 Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (=0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008 24 Weeks
Secondary Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24 Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24 24 Weeks
Secondary Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 Day 1
Secondary Time to first severe asthma exacerbation Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Time to first severe asthma exacerbation
Up to 52 Weeks
Secondary Rate of moderate/severe asthma exacerbations Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Rate of moderate/severe asthma exacerbations
Up to 52 Weeks
Secondary Time to first moderate/severe asthma exacerbation Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008:
Time to first moderate/severe asthma exacerbation
Up to 52 Weeks
Secondary Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline. Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline. Up to 52 Weeks
Secondary Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1. Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1. Up to 52 Weeks
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