| January 10, 2008 |
| March 16, 2009 |
| March 2006 |
| |
| Time to first severe asthma exacerbation. Defined 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 |
| 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 |
| Complete list of historical versions of study NCT00628758 on ClinicalTrials.gov Archive Site |
- 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
|
| Same as current |
| |
| A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma |
| 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 |
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. |
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma. |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Asthma |
- Drug: Symbicort TBH
- Drug: beta-II-agonist, inhale steroid
- Behavioral: (AQLQ) diary for patients
- Device: Vitalograph peak flow meter
|
| |
| |
| |
| Completed |
| 1000 |
| September 2008 |
|
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 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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Turkey |
| |
| NCT00628758 |
| AstraZeneca, Turkey Clinical Study Information |
| D5890L00016 |
| AstraZeneca |
|
| Principal Investigator: |
Zeynep Misirligil |
Ankara Univ. Med. Fac, Chest Disease Dept |
|
|
| AstraZeneca |
| March 2009 |
