A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg

Asthma Clinical Trial

— CHASE 3  

Official title:

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091986
• Other study ID #: D589GC00003
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2014
• Last updated: April 22, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.

Description:

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2

• Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal

• Demonstrated reversibility of clinic FEV1 of =12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

Exclusion Criteria:

• Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1

• Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort pMDI
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
• Symbicort pMDI
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Other:
• Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily

Locations

Country	Name	City	State
Mexico	Research Site	Cuautitlan Izcalli
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Panama	Research Site	Ciudad de Panama
Panama	Research Site	David Chiriqui
Panama	Research Site	Panama
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Poprad
Slovakia	Research Site	Presov
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Allen	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Baytown	Texas
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Canton	Ohio
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Coral Gables	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Edmond	Oklahoma
United States	Research Site	El Paso	Texas
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fort Walton Beach	Florida
United States	Research Site	Fort Worth	Texas
United States	Research Site	Gilbert	Arizona
United States	Research Site	Gresham	Oregon
United States	Research Site	Hialeah	Florida
United States	Research Site	Homestead	Florida
United States	Research Site	Hoover	Alabama
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Beach	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Katy	Texas
United States	Research Site	Kerville	Texas
United States	Research Site	Largo	Florida
United States	Research Site	Lenexa	Kansas
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Medford	Oregon
United States	Research Site	Miami	Florida
United States	Research Site	Mission Viejo	California
United States	Research Site	Montgomery	Alabama
United States	Research Site	Murray	Utah
United States	Research Site	Newport Beach	California
United States	Research Site	North Charleston	South Carolina
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Ontario	California
United States	Research Site	Plymouth	Minnesota
United States	Research Site	Portland	Oregon
United States	Research Site	Richmond	Texas
United States	Research Site	Rockville Centre	New York
United States	Research Site	San Antonio	Texas
United States	Research Site	Savannah	Georgia
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Stockton	California
United States	Research Site	Tacoma	Washington
United States	Research Site	Toledo	Ohio
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Verona	New Jersey
United States	Research Site	Waco	Texas
United States	Research Site	Waldorf	Maryland
United States	Research Site	Walnut Creek	California
United States	Research Site	Washington	Washington
United States	Research Site	Watertown	New York
United States	Research Site	West Columbia	South Carolina
United States	Research Site	Williston	Florida
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Mexico,  Panama,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in one-hour post-dose forced expiratory volume in the first second (FEV1)	Change from baseline to Week 12 in one-hour post-dose FEV1	Baseline to Week 12	No
Secondary	Change from baseline in one-hour post-dose clinic FVC (L)	Change from baseline to one-hour post-dose FVC at Weeks 2, 4, 8 and 12	Baseline taken at Week 0 then at Weeks 2, 4, 8 and 12	No
Secondary	Change from baseline in one-hour post-dose clinic FEF25-75 (L/s) measured in the clinic	Change from baseline to one-hour post-dose FEF25-75 at Weeks 2, 4, 8 and 12	Baseline taken at Week 0 then at Weeks 2,4,8 and 12	No
Secondary	Change from baseline in one-hour post-dose peak expiratory flow (PEF) (L/min) measured in the clinic (clinic PEF)	Change from baseline to one-hour post-dose PEF at Weeks 2, 4, 8 and 12	Baseline taken at Week 0 then at Weeks 2,4,8 and 12	No
Secondary	Change from baseline in one-hour post-dose FEV1	Change from baseline in one-hour post dose FEV1 at Weeks 2, 4 and 8	Weeks 2, 4 and 8	No
Secondary	Change from baseline in pre-dose clinic FEV1 in liter (L).	Change from baseline to pre-dose FEV1 at Weeks 2,4,8 and 12	Baseline to Week 2,4,8 and12	No
Secondary	Change from baseline in pre-dose clinic FVC (L)	Change from baseline to pre-dose FVC (L) at Weeks 2,4,8 and 12	Baseline to Week 2,4,8 and12	No
Secondary	Change from baseline in pre-dose clinic FEF25-75 (L/s)	Change from baseline to pre-dose FEF25-75 at Weeks 2,4,8 and 12	Baseline to Week 2,4,8 and12	No
Secondary	Change from baseline in pre-dose clinic Peak expiratory flow (PEF) (L/min)	Change from baseline to pre-dose PEF at Weeks 2, 4, 8 and 12	Baseline to Week 2, 4, 8 and12	No
Secondary	Change from baseline in fifteen-minute post-dose clinic FEV1 (L)	Change from baseline to one-hour post-dose FEV1 at Week 12	Baseline taken at Week 0 then at Week 12.	No
Secondary	Change from baseline in fifteen-minute post-dose clinic clinic FVC (L)	Change from baseline to one-hour post-dose FVC at Week 12	Baseline taken at Week 0 then at Week 12.	No
Secondary	Change from baseline in fifteen-minute post-dose clinic FEF25-75 (L/s)	Change from baseline to one-hour post-dose FEF25-75 at Week 12	Baseline taken at Week 0 then at Week 12.	No
Secondary	Change from baseline in fifteen-minute post-dose clinic PEF (L/min)	Change from baseline to one-hour post-dose clinic PEF (L/min) at Week 12	Baseline taken at Week 0 then at Week 12.	No
Secondary	Time to occurrence of first asthma exacerbation	Time in days from randomization until first exacerbation during the 12-week treatment period.	Randomized 12-week treatment period	No
Secondary	Change from baseline in nighttime awakenings due to asthma symptoms requiring reliever use recorded in the eDiary during the single blind run in and the double blind treatment periods	Change in percentage of nighttime awakenings from baseline Treatment Week 12	Baseline taken as percentage of nighttime awakenings during the last 7 days of run-in. Week 12 taken as percentage of nighttime awakenings during Treatment Week 12.	No
Secondary	Change from baseline in paediatric Asthma Quality of Life Questionnaire with Standardised Activities (PAQLQ[S]) scores (overall and each domain)	Change from baseline PAQLQ(S) to mean of Weeks 4, 8 and 12	Baseline taken at Week 0 then at Weeks 4, 8 and 12	No
Secondary	Change from baseline in morning and evening FEV1 (L) recorded in the electronic diary (eDiary)	Change from baseline mean in diary FEV1 to mean at Week 12	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in nighttime reliever medication use recorded in the eDiary	Change from mean baseline to Treatment Week 12 mean in nighttime reliever medication use.	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in daytime reliever medication use recorded in the eDiary	Change from mean baseline to Treatment Week 12 mean in daytime reliever medication use.	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in total daily reliever medication use recorded in the eDiary	Change from mean baseline to Treatment Week 12 mean in total reliever medication use.	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in nighttime asthma symptom scores recorded in the eDiary	Change from mean baseline score to mean score during Week 12	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in daytime asthma symptom scores recorded in the eDiary	Change from mean baseline score to mean score during Week 12	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Change from baseline in total daily asthma symptom scores recorded in the eDiary	Change from mean baseline score to mean score during Week 12	Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period.	No
Secondary	Time to discontinuation of investigational product (IP).	Time in days from randomization until discontinuation of investigational product during the 12-week treatment period	Randomized 12-week treatment period	No