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

Primary Purpose

Asthma, Bronchial

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Symbicort (budesonide/formoterol) Turbuhaler
Conventional treatment
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma, Bronchial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Outcomes

Primary Outcome Measures

Time to First Severe Asthma Exacerbation
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.

Secondary Outcome Measures

Total Number of Severe Exacerbations
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Mean Use of as Needed Medication
Mean use of as needed medication during the treatment period
Use of Inhaled Steroids
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Change in the Asthma Control Questionnaire(ACQ) Score
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF)

Full Information

First Posted
October 6, 2006
Last Updated
November 30, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00385593
Brief Title
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Official Title
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Symbicort (budesonide/formoterol) Turbuhaler
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Primary Outcome Measure Information:
Title
Time to First Severe Asthma Exacerbation
Description
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
Time Frame
Baseline up to 6 months
Secondary Outcome Measure Information:
Title
Total Number of Severe Exacerbations
Description
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Time Frame
Baseline up to 6 months
Title
Mean Use of as Needed Medication
Description
Mean use of as needed medication during the treatment period
Time Frame
Baseline up to 6 months
Title
Use of Inhaled Steroids
Description
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Time Frame
Baseline up to 6 months
Title
Change in the Asthma Control Questionnaire(ACQ) Score
Description
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Time Frame
Daily 14 days prior to each of visit 2-4
Title
Peak Expiratory Flow (PEF)
Description
Peak expiratory flow (PEF)
Time Frame
6 months (end of the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Barcina, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
A Coruna
Country
Spain
Facility Name
Research Site
City
Alagon
Country
Spain
Facility Name
Research Site
City
Alicante
Country
Spain
Facility Name
Research Site
City
Almoradi
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Burgos
Country
Spain
Facility Name
Research Site
City
Cadiz
Country
Spain
Facility Name
Research Site
City
Caravaca
Country
Spain
Facility Name
Research Site
City
Cartagena
Country
Spain
Facility Name
Research Site
City
Cordoba
Country
Spain
Facility Name
Research Site
City
Coslada
Country
Spain
Facility Name
Research Site
City
Dos Hermanas
Country
Spain
Facility Name
Research Site
City
Elche
Country
Spain
Facility Name
Research Site
City
Fuencarral
Country
Spain
Facility Name
Research Site
City
Fuenlabrada
Country
Spain
Facility Name
Research Site
City
Galdacano
Country
Spain
Facility Name
Research Site
City
Gallur
Country
Spain
Facility Name
Research Site
City
Gandia
Country
Spain
Facility Name
Research Site
City
Getafe
Country
Spain
Facility Name
Research Site
City
Gijon
Country
Spain
Facility Name
Research Site
City
Granada
Country
Spain
Facility Name
Research Site
City
Huelva
Country
Spain
Facility Name
Research Site
City
Huesca
Country
Spain
Facility Name
Research Site
City
Idiazabal
Country
Spain
Facility Name
Research Site
City
Jaen
Country
Spain
Facility Name
Research Site
City
Lugo
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Mataro
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Pamplona
Country
Spain
Facility Name
Research Site
City
Pinto
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
Country
Spain
Facility Name
Research Site
City
Sagunto
Country
Spain
Facility Name
Research Site
City
Salamanca
Country
Spain
Facility Name
Research Site
City
San Juan
Country
Spain
Facility Name
Research Site
City
San Sebastian
Country
Spain
Facility Name
Research Site
City
Santander
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Santiago
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Terrassa
Country
Spain
Facility Name
Research Site
City
Valdemoro
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Valladolid
Country
Spain
Facility Name
Research Site
City
Vigo
Country
Spain
Facility Name
Research Site
City
Viladecans
Country
Spain
Facility Name
Research Site
City
Vilanova
Country
Spain
Facility Name
Research Site
City
Villabona
Country
Spain
Facility Name
Research Site
City
Villanueva de la Canada
Country
Spain
Facility Name
Research Site
City
Vitoria
Country
Spain
Facility Name
Research Site
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

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

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