Study to Investigate the Efficacy of Symbicort® SMART.

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler

• Registration Number: NCT00839800
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-21
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Results First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2091

Inclusion Criteria

• Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
• Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
• Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Exclusion Criteria

• Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
• Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Terbutaline Turbuhaler	Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
2	Symbicort Turbuhaler	Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
1	Symbicort Turbuhaler	Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study	week 52	Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.

Secondary Outcome Measures

Name	Time	Method
Morning Peak Expiratory Flow (PEF)	52-week treatment period	The mean value from a 52-week treatment period.
Forced Expiratory Volume in One Second (FEV1)	4, 12, 24, 36 and 52 weeks after randomization	The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
Nights With Awakening(s) Due to Asthma Symptoms	52-week treatment period	The mean value from the treatment period was presented here.
Number of Asthma Exacerbations	up to 52 weeks	Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.
Symptom-free Days (no Symptoms and no Awakenings)	52-week treatment period	A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.
Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)	52-week treatment period	An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.
Asthma Control Questionnaire (ACQ)	4, 12, 24, 36 and 52 weeks after randomization	The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.
Evening PEF	2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period	The mean value from a 52-week treatment period.
Use of As-needed Medication	52-week treatment period	The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations	up to 52 weeks	Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.
Percentage of As-needed-free Days	52-week treatment period	An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.
Asthma Symptom Score	52-week treatment period	The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).

Trial Locations

Locations (1)

Research Site; 🇹🇭 Khon Kaen, Thailand