An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

Asthma Clinical Trial

Official title:

A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419757
• Other study ID #: D5896C00021
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: August 24, 2012
• Start date: January 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2012
• 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 of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or Female, Hispanic (self-reported), > 12 years of age

• Moderate to severe asthma requiring treatment with an inhaled corticosteroid

• Diagnosis of asthma for at least 6 months

Exclusion Criteria:

• Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)

• Any significant disease or disorder that may jeopardize a subject's safety

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:
• Budesonide/formoterol (SYMBICORT) pMDI
SYMBICORT® pMDI 160/4.5 µg x 2 actuations twice daily
• Budesonide HFA pMDI
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 µg x 2 actuations twice daily

Locations

Country	Name	City	State
Puerto Rico	Research Site	Aguas Buenas
Puerto Rico	Research Site	Caquas
Puerto Rico	Research Site	Cidra
Puerto Rico	Research Site	Levittown
Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	SanJuan
Puerto Rico	Research Site	Trujillo Alto
United States	Research Site	Anaheim	California
United States	Research Site	Boerne	Texas
United States	Research Site	Chicago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	El Paso	Texas
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fresno	California
United States	Research Site	Fullerton	California
United States	Research Site	Houston	Texas
United States	Research Site	Largo	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	Miami	Florida
United States	Research Site	Naranja	Florida
United States	Research Site	National City	California
United States	Research Site	Newburgh	New York
United States	Research Site	North Miami	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Panama City	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pueblo	Colorado
United States	Research Site	Rancho Cordova	California
United States	Research Site	Rancho Mirage	California
United States	Research Site	Riverside	California
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	South Miami	Florida
United States	Research Site	Spring	Texas
United States	Research Site	Stockton	California
United States	Research Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning Peak Expiratory Flow (AM PEF)	Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Percentage of Participants With Pre-defined Asthma Events	Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication	12 weeks	No
Secondary	Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"	Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	12 weeks	No
Secondary	Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline, 2, 6 and 12 weeks	No
Secondary	Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)	Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks	Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.; Daily scale: 0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks	Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.; Daily scale: 0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks	Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment	Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment	Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment	Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks	No
Secondary	Subject Global Assessment	The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.	Baseline and week 12	No
Secondary	Physician Global Assessment	The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.	Baseline and week 12	No
Secondary	Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index	Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12	No
Secondary	Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication	Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12	No
Secondary	Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications	Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12	No