Study to Investigate the Efficacy of Symbicort® SMART. (SAKURA)

November 26, 2012 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2091

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • 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
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Brazil
    • Brasil
      • Porto Alegre, Brasil, Brazil
        • Research Site
    • MG
      • Belo Horizonte, MG, Brazil
        • Research Site
      • Juiz de Fora, MG, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Santo Andre, SP, Brazil
        • Research Site
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil
        • Research Site
  • China
      • Chongqing, China
        • Research Site
      • Guang Zhou, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Qingdao, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Xi An, China
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site
  • Costa Rica
    • Cartago
      • Tres Rios, Cartago, Costa Rica
        • Research Site
    • San Jose
      • Barrio San Bosco, San Jose, Costa Rica
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Cegled, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Deszk, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szazhalombatta, Hungary
        • Research Site
  • India
      • Noida, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
      • Mysore, Karnataka, India
        • Research Site
    • Kerala
      • Trivandrum, Kerala, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Nagpur, Maharashtra, India
        • Research Site
      • Pune, Maharashtra, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Tamilnadu
      • Coimabatore, Tamilnadu, India
        • Research Site
  • Japan
      • Fukuoka, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
    • Aichi
      • Komaki, Aichi, Japan
        • Research Site
      • Seto, Aichi, Japan
        • Research Site
    • Chiba
      • Asahi, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
        • Research Site
      • Yanagawa, Fukuoka, Japan
        • Research Site
    • Gunma
      • Isesaki, Gunma, Japan
        • Research Site
      • ORA, Gunma, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
      • Hiroshima-shi, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Chitose, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Hyogo
      • AKO, Hyogo, Japan
        • Research Site
      • Himeji, Hyogo, Japan
        • Research Site
      • Kobe-city, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Hitachi, Ibaraki, Japan
        • Research Site
      • Naka-gun, Ibaraki, Japan
        • Research Site
    • Iwate
      • Morioka, Iwate, Japan
        • Research Site
    • Kagawa
      • Sakaide, Kagawa, Japan
        • Research Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Research Site
      • Kawasaki-shi, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Niigata
      • Nagaoka, Niigata, Japan
        • Research Site
    • Oita
      • Beppu, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Osaka
      • Sakai, Osaka, Japan
        • Research Site
    • Shimane
      • Matsue, Shimane, Japan
        • Research Site
    • Tochigi
      • Utsunomiya, Tochigi, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site
      • Itabashi, Tokyo, Japan
        • Research Site
      • Kodaira, Tokyo, Japan
        • Research Site
      • Kokubunji, Tokyo, Japan
        • Research Site
      • Machida, Tokyo, Japan
        • Research Site
      • Nakano-ku, Tokyo, Japan
        • Research Site
      • Toshima-ku, Tokyo, Japan
        • Research Site
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Research Site
      • Cheongju, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon, Korea, Republic of
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Penang, Malaysia
        • Research Site
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia
        • Research Site
    • Pahang
      • Kuantan, Pahang, Malaysia
        • Research Site
    • Selangor
      • Batu Caves, Selangor, Malaysia
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
    • Lima
      • Surco, Lima, Peru
        • Research Site
  • Philippines
      • Davao City, Philippines
        • Research Site
      • Iloilo City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
    • Batangas
      • Lipa City, Batangas, Philippines
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand
        • Research Site
    • Nakhonratchasima
      • Naimuang, Nakhonratchasima, Thailand
        • Research Site
    • Songkla
      • Hat Yai, Songkla, Thailand
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
Drug: Symbicort Turbuhaler
160/4.5 µg
Active Comparator: 2
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Drug: Symbicort Turbuhaler
160/4.5 µg
Drug: Terbutaline Turbuhaler
0.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 52 weeks
Morning Peak Expiratory Flow (PEF)
Time Frame: 52-week treatment period
The mean value from a 52-week treatment period.
52-week treatment period
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.
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)
Time Frame: 4, 12, 24, 36 and 52 weeks after randomization
The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
4, 12, 24, 36 and 52 weeks after randomization
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).
52-week treatment period
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).
52-week treatment period
Nights With Awakening(s) Due to Asthma Symptoms
Time Frame: 52-week treatment period
The mean value from the treatment period was presented here.
52-week treatment period
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.
up to 52 weeks
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.
52-week treatment period
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.
52-week treatment period
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.
52-week treatment period
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.
4, 12, 24, 36 and 52 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Tito Atienza, M.D., Mary Mediatrix Medical Center, Lipa City, Philippines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589LC00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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