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® pressurised MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

Conditions

Severe and inadequately controlled asthma

Brief summary

Primary end point(s) of D5982C00007. 1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks. Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008. 1. Rate of severe asthma exacerbations.

Detailed description

Secondary end point(s) of D5982C00007. 1. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1., 2. Change from baseline in FEV1 AUC0-3 over 24 Weeks, 3. Percentage of responders in ACQ-7 (≥0.5 decrease equals response) over 24 weeks., 4. Percentage of responders in ACQ-5 (≥0.5 decrease equals response) over 24 weeks., 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., 6. Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24., 7. Rate of severe asthma exacerbations over the Treatment Period, Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first moderate/severe asthma exacerbation., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤ 55% at baseline., Secondary end point 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.

Related papers

No related papers found yet.

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPREDNISOLONE

DRUGPlacebo pMDI to match Budesonide/Formoterol Fumarate pMDI

DRUGPlacebo MDI match Budesonide

DRUGGlycopyronium and Formoterol Fumarate/ Budesonide and Formoterol Fumarate MDI

DRUGSymbicort

DRUG160 mikrogram/4

DRUG5 mikrogram/puff inhalationsspray

DRUGsuspension

DRUGTrixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation

DRUGBudesonide

DRUGGlycopyronium and Formoterol Fumarate

DRUGSALBUTAMOL

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary end point(s) of D5982C00007. 1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks. Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008. 1. Rate of severe asthma exacerbations.	—

Secondary

Measure	Time frame
Secondary end point(s) of D5982C00007. 1. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1., 2. Change from baseline in FEV1 AUC0-3 over 24 Weeks, 3. Percentage of responders in ACQ-7 (≥0.5 decrease equals response) over 24 weeks., 4. Percentage of responders in ACQ-5 (≥0.5 decrease equals response) over 24 weeks., 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., 6. Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24., 7. Rate of severe asthma exacerbations over the Treatment Period, Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first mo	—

Measure

Time frame

Secondary end point(s) of D5982C00007. 1. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1., 2. Change from baseline in FEV1 AUC0-3 over 24 Weeks, 3. Percentage of responders in ACQ-7 (≥0.5 decrease equals response) over 24 weeks., 4. Percentage of responders in ACQ-5 (≥0.5 decrease equals response) over 24 weeks., 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., 6. Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24., 7. Rate of severe asthma exacerbations over the Treatment Period, Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations., Secondary end point of Pooled Studies D5982C00007 and D5982C00008: Time to first mo

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Countries

Bulgaria, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed