Study to Investigate the Efficacy of Symbicort® SMART.

NCT ID: NCT00839800

Last Updated: 2012-11-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2091 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Asthma

Keywords

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Asthma Symbicort Turbuhaler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed

Group Type EXPERIMENTAL

Symbicort Turbuhaler

Intervention Type DRUG

160/4.5 µg

2

Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed

Group Type ACTIVE_COMPARATOR

Symbicort Turbuhaler

Intervention Type DRUG

160/4.5 µg

Terbutaline Turbuhaler

Intervention Type DRUG

0.4 mg

Interventions

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Symbicort Turbuhaler

160/4.5 µg

Intervention Type DRUG

Terbutaline Turbuhaler

0.4 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Andersson, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Lund

Tito Atienza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mary Mediatrix Medical Center, Lipa City, Philippines

Locations

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Research Site

Buenos Aires, Argentina, Argentina

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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 Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Ciudad de Buenos Aires, , Argentina

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Porto Alegre, Brasil, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Florianópolis, Santa Catarina, Brazil

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Santo André, São Paulo, Brazil

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Shenyang, Liaoning, China

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Hangzhou, Zhejiang, China

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Chongqing, , China

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Guangzhou, , 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

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Tres Ríos, Cartago Province, Costa Rica

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Barrio San Bosco, Provincia de San José, Costa Rica

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Budapest, , Hungary

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Cegléd, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Gyula, , Hungary

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Nyíregyháza, , Hungary

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Százhalombatta, , Hungary

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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, Tamil Nadu, India

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Noida, , India

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Komaki, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Asahi, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Yanagawa, Fukuoka, Japan

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Isesaki, Gunma, Japan

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Ōwa, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Hiroshima, 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, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Kobe, Hyōgo, 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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Sakaidechō, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, 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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Kochi, Kochi, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Nagaoka, Niigata, Japan

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Niigata, Niigata, Japan

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Beppu, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, 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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Chūō, 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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tabashi City, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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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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George Town, , Malaysia

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Kuala Lumpur, , Malaysia

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Lima, Lima Province, Peru

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Surco, Lima region, Peru

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Lipa City, Batangas, Philippines

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Davao City, Philippines, Philippines

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Iloilo City, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Bucheon-si, , South Korea

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Cheongju-si, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Bangkoknoi, Bangkok, Thailand

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Hat Yai, Changwat Songkhla, Thailand

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Naimuang, Nakhonratchasima, Thailand

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Bangkok, Thailand, Thailand

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Khon Kaen, , Thailand

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Countries

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Russia Argentina Brazil China Costa Rica Hungary India Japan Malaysia Peru Philippines South Korea Thailand

References

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Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.

Reference Type DERIVED
PMID: 32718193 (View on PubMed)

Other Identifiers

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D589LC00001

Identifier Type: -

Identifier Source: org_study_id