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Completed

NCT Number: NCT00839800

Study to Investigate the Efficacy of Symbicort® SMART.

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbicort Turbuhaler

Drug

160/4.5 µg

Terbutaline Turbuhaler

Drug

0.4 mg

Primary outcomes

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

    Time frame: week 52

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

Secondary outcomes

  1. Number of Asthma Exacerbations

    Time frame: 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.

  2. Morning Peak Expiratory Flow (PEF)

    Time frame: 52-week treatment period

    The mean value from a 52-week treatment period.

  3. Evening PEF

    Time frame: 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.

  4. Forced Expiratory Volume in One Second (FEV1)

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

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

  5. Use of As-needed Medication

    Time frame: 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).

  6. Asthma Symptom Score

    Time frame: 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).

  7. Nights With Awakening(s) Due to Asthma Symptoms

    Time frame: 52-week treatment period

    The mean value from the treatment period was presented here.

  8. The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations

    Time frame: 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.

  9. Symptom-free Days (no Symptoms and no Awakenings)

    Time frame: 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.

  10. Percentage of As-needed-free Days

    Time frame: 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.

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

    Time frame: 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.

  12. Asthma Control Questionnaire (ACQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years

Acronym: SAKURA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2009
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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