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

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00385593
First received: October 6, 2006
Last updated: November 30, 2010
Last verified: November 2010

October 6, 2006
November 30, 2010
September 2006
Not Provided
Time to First Severe Asthma Exacerbation [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
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.
The primary outcome variable will be time to first severe asthma exacerbations. Exacerbations are considered an appropriate outcome variable by CPMP The definition of a severe asthma exacerbation is based on the same guideline.
Complete list of historical versions of study NCT00385593 on ClinicalTrials.gov Archive Site
  • Total Number of Severe Exacerbations [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    Mean use of as needed medication during the treatment period
  • Use of Inhaled Steroids [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
  • Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: Daily 14 days prior to each of visit 2-4 ] [ Designated as safety issue: No ]
    The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
  • Peak Expiratory Flow (PEF) [ Time Frame: 6 months (end of the study) ] [ Designated as safety issue: No ]
    Peak expiratory flow (PEF)
A secondary objective is to collect safety data for treatment in the two treatment groups in adult patients with persistent asthma
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma, Bronchial
  • Drug: Symbicort (budesonide/formoterol) Turbuhaler
  • Drug: Conventional treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
654
October 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00385593
D5890L00010, 2005-005974-64, SPAIN
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Carlos Barcina, MD AstraZeneca
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP