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

Condition(s) targeted: Persistent Asthma

Intervention: Symbicort TBH (Drug); beta-II-agonist, inhale steroid (Drug); (AQLQ) diary for patients (Behavioral); Vitalograph peak flow meter (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Zeynep Misirligil, Principal Investigator, Affiliation: Ankara Univ. Med. Fac, Chest Disease Dept

Overall contact:
AstraZeneca Turkey Clinical Study, Phone: 0090 212 317 28 80, Email: ozlem.kaya@astrazeneca.com

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.

Official title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5mg, 1 Inhalation 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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to first severe asthma exacerbation. Defined as deterioration in asthma leading to at least one of the following:1. Hospitalisation/Emergency room (or equivalent) treatment due to asthma 2. Oral GC treatment due to asthma for at least 3 days

Secondary outcome:

Number of severe asthma exacerbations

Change in AQLQ(S) score from randomisation (visit 1) to Visits 4

Mean use of as-needed medication per day during treatment period

Prescribed asthma medication during the 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.

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 Throacic

Society (ATS) definition

- Perscribed inhaled GCS at a dose of 320mg/day and within the approved lable 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 enrolment 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 enrolment

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

AstraZeneca Turkey Clinical Study, Phone: 0090 212 317 28 80, Email: ozlem.kaya@astrazeneca.com

Research Site, Ankara, Turkey; Recruiting

Research Site, Antalya, Turkey; Recruiting

Research Site, Bolu, Turkey; Recruiting

Research Site, Denizli, Turkey; Recruiting

Research Site, Diyarbakir, Turkey; Recruiting

Research Site, Edirne, Turkey; Recruiting

Research Site, Erzurum, Turkey; Recruiting

Research Site, Eskisehir, Turkey; Recruiting

Research Site, Istanbul, Turkey; Recruiting

Research Site, Izmir, Turkey; Recruiting

Research Site, Kocaeli, Turkey; Recruiting

Research Site, Konya, Turkey; Recruiting

Research Site, Malatya, Turkey; Recruiting

Research Site, Manisa, Turkey; Recruiting

Research Site, Mersin, Turkey; Recruiting

Research Site, Samsun, Turkey; Recruiting

Research Site, Zonguldak, Turkey; Recruiting

Research Site, Bursa, Grukle, Turkey; Recruiting

Starting date: March 2006
Last updated: February 25, 2008