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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 Exacerbations

Change 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

Page last updated: August 23, 2015

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