Study to Investigate the Efficacy of Symbicort® SMART.

AstraZeneca2,091 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,091

Conditions

Asthma

Interventions

Symbicort TurbuhalerDRUG

160/4.5 µg

Terbutaline TurbuhalerDRUG

0.4 mg

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (109)

Outcomes

Primary Outcomes

The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study

Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.

Time frame: week 52

Secondary Outcomes

Number of Asthma Exacerbations

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.

Time frame: up to 52 weeks

Morning Peak Expiratory Flow (PEF)

The mean value from a 52-week treatment period.

Time frame: 52-week treatment period

Evening PEF

The mean value from a 52-week treatment period.

Time frame: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period

Forced Expiratory Volume in One Second (FEV1)

The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.

Time frame: 4, 12, 24, 36 and 52 weeks after randomization

Use of As-needed Medication

The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).

Time frame: 52-week treatment period

Asthma Symptom Score

The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).

Data from ClinicalTrials.gov

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Research Site

Buenos Aires, Argentina, Argentina

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Monte Grande, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Santa Fe, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Porto Alegre, Brasil, Brazil

...and 99 more locations

Time frame: 52-week treatment period

Nights With Awakening(s) Due to Asthma Symptoms

The mean value from the treatment period was presented here.

Time frame: 52-week treatment period

The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations

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.

Time frame: up to 52 weeks

Symptom-free Days (no Symptoms and no Awakenings)

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.

Time frame: 52-week treatment period

Percentage of As-needed-free Days

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.

Time frame: 52-week treatment period

Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)

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.

Time frame: 52-week treatment period

Asthma Control Questionnaire (ACQ)

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.

Time frame: 4, 12, 24, 36 and 52 weeks after randomization