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Phase 3 Completed N=430 Randomized Treatment

A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

Source: ClinicalTrials.gov NCT00628758 ↗
Enrolled (actual)
430
Serious AEs
0.9%
Results posted
Aug 2012
Primary outcomePrimary: Time to First Severe Asthma Exacerbation — 120.3; 103.7 days

Summary

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to First Severe Asthma Exacerbation
120.3; 103.7
SECONDARY
Number of Severe Asthma Exacerbations
10; 10
SECONDARY
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
3.98; 3.97
SECONDARY
Mean Use of As-needed Medication Per Day During Treatment Period
0.91; 0.68

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
  • Ability to read and write in Turkish
  • Female or male outpatients aged 18 years
  • Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
  • Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day 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 long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment

Exclusion Criteria

  • Previous treatment with Symbicort Single inhaler Therapy
  • Use of any b-blocking agent, including eye drops
  • Use of oral GCS as maintenance treatment
  • Known or suspected hypersensitivity to study therapy or excipients
  • A history of smoking 10 pack years
  • Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
  • Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00628758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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