Study to Investigate the Efficacy of Symbicort® SMART. - Full Text View

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Symbicort Turbuhaler Drug: Terbutaline Turbuhaler	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.

Secondary Outcome Measures:

Number of Asthma Exacerbations [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
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.
Morning Peak Expiratory Flow (PEF) [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
The mean value from a 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 ] [ Designated as safety issue: No ]
The mean value from a 52-week treatment period.
Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ] [ Designated as safety issue: No ]
The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
Use of As-needed Medication [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
Asthma Symptom Score [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).
Nights With Awakening(s) Due to Asthma Symptoms [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
The mean value from the treatment period was presented here.
The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
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.
Symptom-free Days (no Symptoms and no Awakenings) [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
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 As-needed-free Days [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
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.
Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
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) [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ] [ Designated as safety issue: No ]
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.

Enrollment:	2091
Study Start Date:	February 2009
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839800

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Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson, MD	AstraZeneca R&D Lund
Principal Investigator:	Tito Atienza, M.D.	Mary Mediatrix Medical Center, Lipa City, Philippines

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00839800 History of Changes
Other Study ID Numbers:	D589LC00001
Study First Received:	February 4, 2009
Results First Received:	February 21, 2012
Last Updated:	November 26, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency China: Ministry of Health China: Food and Drug Administration Costa Rica: CEC-UCIMED Hungary: National Institute of Pharmacy India: Drugs Controller General of India Japan: Ministry of Health, Labor and Welfare Malaysia: Ministry of Health Philippines: Bureau of Food and Drugs Russia: Ministry of Health of the Russian Federation South Korea: Korea Food and Drug Administration (KFDA) Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids

ClinicalTrials.gov processed this record on May 23, 2013

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