A Comparison of Symbicort� Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Symbicort TBH - Turbuhaler (Drug); beta-II-agonist, inhale steroid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Zeynep Misirligil, Principal Investigator, Affiliation: Ankara Univ. Med. Fac, Chest Disease Dept
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.
Clinical Details
Official title: A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to First Severe Asthma Exacerbation
Secondary outcome: Number of Severe Asthma ExacerbationsChange in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score Mean Use of As-needed Medication Per Day During Treatment Period
Detailed description:
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler
Therapy in adult patients with persistent asthma.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Ankara, Turkey
Research Site, Antalya, Turkey
Research Site, Bursa, Turkey
Research Site, Denizli, Turkey
Research Site, Diyarbakir, Turkey
Research Site, Edirne, Turkey
Research Site, Eski?ehir, Turkey
Research Site, Istanbul, Turkey
Research Site, Izmir, Turkey
Research Site, Kocaeli, Turkey
Research Site, Malatya, Turkey
Research Site, Manisa, Turkey
Research Site, Mersin, Turkey
Research Site, Samsun, Turkey
Research Site, Zonguldak, Turkey
Additional Information
Starting date: December 2005
Last updated: July 6, 2012
|