Clinical trial NCT00628758: A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Symbicort
Turbuhaler
Persistent Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

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

Primary outcomes:
measure: Time to First Severe Asthma Exacerbation
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of Severe Asthma Exacerbations
timeFrame: 26 weeks
measure: Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
timeFrame: Baseline and 26 weeks
measure: Mean Use of As-needed Medication Per Day During Treatment Period
timeFrame: Daily recording during the treatment period of 26 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Denizli
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Edirne
country: Turkey
facility: Research Site
city: Eski?ehir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Zonguldak
country: Turkey
facility: Research Site
Study officials:
affiliation: Ankara Univ. Med. Fac, Chest Disease Dept
name: Zeynep Misirligil
role: PRINCIPAL_INVESTIGATOR
References: