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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628758

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Salmeterol xinafoate Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1000
Study Start Date:	March 2006
Study Completion Date:	September 2008

Intervention Details:

Salbulin inh. 200-400 dosage 100 mcg/dosage Salbutam SR caps 4 mg/8 mg Salbutol tb 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb,syrup, IV (5mg x10amp) Ventolin inh 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage

Model 4300 EN 13826 Cap no: 43600

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628758

Locations

Turkey
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
Zonguldak, 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
Istanbul, Turkey

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Zeynep Misirligil

Ankara Univ. Med. Fac, Chest Disease Dept

More Information

No publications provided

Responsible Party:	Turkey Clinical Study Information ( AstraZeneca )
Study ID Numbers:	D5890L00016
Study First Received:	January 10, 2008
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00628758 History of Changes
Health Authority:	Turkey: Ministry of Health

Keywords provided by AstraZeneca:

Symbicort
Turbuhaler
Persistent Asthma

Study placed in the following topic categories:

Salmeterol
Bronchial Diseases
Symbicort
Albuterol
Anti-Asthmatic Agents
Asthma
Terbutaline

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Formoterol
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009