Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
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
3 other identifiers
interventional
654
1 country
52
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2006
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 9, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
November 17, 2009
CompletedDecember 16, 2010
November 1, 2010
October 6, 2006
October 14, 2009
November 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to 6 months
Secondary Outcomes (5)
Total Number of Severe Exacerbations
Baseline up to 6 months
Mean Use of as Needed Medication
Baseline up to 6 months
Use of Inhaled Steroids
Baseline up to 6 months
Change in the Asthma Control Questionnaire(ACQ) Score
Daily 14 days prior to each of visit 2-4
Peak Expiratory Flow (PEF)
6 months (end of the study)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (52)
Research Site
A Coruña, Spain
Research Site
Alagón, Spain
Research Site
Alicante, Spain
Research Site
Almoradí, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Cadiz, Spain
Research Site
Caravaca, Spain
Research Site
Cartagena, Spain
Research Site
Coslada, Spain
Research Site
Córdoba, Spain
Research Site
Donostia / San Sebastian, Spain
Research Site
Dos Hermanas, Spain
Research Site
Elche, Spain
Research Site
Fuencarral, Spain
Research Site
Fuenlabrada, Spain
Research Site
Galdakao, Spain
Research Site
Gallur, Spain
Research Site
Gandia, Spain
Research Site
Getafe, Spain
Research Site
Gijón, Spain
Research Site
Granada, Spain
Research Site
Huelva, Spain
Research Site
Huesca, Spain
Research Site
Idiazabal, Spain
Research Site
Jaén, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Mataró, Spain
Research Site
Málaga, Spain
Research Site
Oviedo, Spain
Research Site
Pamplona, Spain
Research Site
Pinto, Spain
Research Site
Pozuelo de Alarcón, Spain
Research Site
Sagunto, Spain
Research Site
Salamanca, Spain
Research Site
San Juan, Spain
Research Site
Santander, Spain
Research Site
Santiago, Spain
Research Site
Santiago de Compostela, Spain
Research Site
Seville, 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 Cañada, Spain
Research Site
Vitoria-Gasteiz, Spain
Research Site
Zaragoza, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely stopped, because it was not possible to recruit the sample size required in the period of time established.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Carlos Barcina, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 9, 2006
Study Start
September 1, 2006
Study Completion
October 1, 2008
Last Updated
December 16, 2010
Results First Posted
November 17, 2009
Record last verified: 2010-11