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

November 30, 2010 updated by: AstraZeneca

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

654

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

  • Spain
      • A Coruna, Spain
        • Research Site
      • Alagon, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Almoradi, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Cadiz, Spain
        • Research Site
      • Caravaca, Spain
        • Research Site
      • Cartagena, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Coslada, Spain
        • Research Site
      • Dos Hermanas, Spain
        • Research Site
      • Elche, Spain
        • Research Site
      • Fuencarral, Spain
        • Research Site
      • Fuenlabrada, Spain
        • Research Site
      • Galdacano, Spain
        • Research Site
      • Gallur, Spain
        • Research Site
      • Gandia, Spain
        • Research Site
      • Getafe, Spain
        • Research Site
      • Gijon, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Huelva, Spain
        • Research Site
      • Huesca, Spain
        • Research Site
      • Idiazabal, Spain
        • Research Site
      • Jaen, Spain
        • Research Site
      • Lugo, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Mataro, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Pamplona, Spain
        • Research Site
      • Pinto, Spain
        • Research Site
      • Pozuelo de Alarcon, Spain
        • Research Site
      • Sagunto, Spain
        • Research Site
      • Salamanca, Spain
        • Research Site
      • San Juan, Spain
        • Research Site
      • San Sebastian, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Santiago, Spain
        • Research Site
      • Santiago de Compostela, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Terrassa, Spain
        • Research Site
      • Valdemoro, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
      • Vigo, Spain
        • Research Site
      • Viladecans, Spain
        • Research Site
      • Vilanova, Spain
        • Research Site
      • Villabona, Spain
        • Research Site
      • Villanueva de la Canada, Spain
        • Research Site
      • Vitoria, Spain
        • Research Site
      • Zaragoza, Spain
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Severe Asthma Exacerbation
Time Frame: Baseline up to 6 months
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.
Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Severe Exacerbations
Time Frame: Baseline up to 6 months
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.
Baseline up to 6 months
Mean Use of as Needed Medication
Time Frame: Baseline up to 6 months
Mean use of as needed medication during the treatment period
Baseline up to 6 months
Use of Inhaled Steroids
Time Frame: Baseline up to 6 months
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Baseline up to 6 months
Change in the Asthma Control Questionnaire(ACQ) Score
Time Frame: Daily 14 days prior to each of visit 2-4
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Daily 14 days prior to each of visit 2-4
Peak Expiratory Flow (PEF)
Time Frame: 6 months (end of the study)
Peak expiratory flow (PEF)
6 months (end of the study)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Carlos Barcina, MD, AstraZeneca

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

September 1, 2006

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 6, 2006

First Posted (Estimate)

October 9, 2006

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00010
  • 2005-005974-64
  • SPAIN

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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