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Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

NCT ID: NCT00385593

Last Updated: 2010-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

654 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Detailed Description

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Conditions

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Asthma, Bronchial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Symbicort (budesonide/formoterol) Turbuhaler

Intervention Type DRUG

Conventional treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
* Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
* Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
* A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
* Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment

Exclusion Criteria

* Previous treatment with Symbicort Single Inhaler;
* Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years.
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Carlos Barcina, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

A Coruña, , Spain

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Alagón, , Spain

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Alicante, , Spain

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Almoradí, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Cadiz, , Spain

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Caravaca, , Spain

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Cartagena, , Spain

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Coslada, , Spain

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Córdoba, , Spain

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Donostia / San Sebastian, , Spain

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Dos Hermanas, , Spain

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Elche, , Spain

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Fuencarral, , Spain

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Fuenlabrada, , Spain

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Galdakao, , Spain

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Gallur, , Spain

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Gandia, , Spain

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Getafe, , Spain

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Gijón, , Spain

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Granada, , Spain

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Huelva, , Spain

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Huesca, , Spain

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Idiazabal, , Spain

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Jaén, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Mataró, , Spain

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Málaga, , Spain

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Oviedo, , Spain

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Pamplona, , Spain

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Pinto, , Spain

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Pozuelo de Alarcón, , Spain

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Sagunto, , Spain

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Salamanca, , Spain

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San Juan, , Spain

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Santander, , Spain

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Santiago, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Terrassa, , Spain

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Valdemoro, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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Vigo, , Spain

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Viladecans, , Spain

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Vilanova, , Spain

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Villabona, , Spain

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Villanueva de la Cañada, , Spain

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Vitoria-Gasteiz, , Spain

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Zaragoza, , Spain

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Countries

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Spain

Other Identifiers

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2005-005974-64

Identifier Type: -

Identifier Source: secondary_id

SPAIN

Identifier Type: -

Identifier Source: secondary_id

D5890L00010

Identifier Type: -

Identifier Source: org_study_id