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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 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

Other Names:

Astmerol inh 25 mcg/dosage, 60-120 dosage
Astmerol maksihaler 50 mcg/dosage, 28-60 dosage
Serevent diskus 50 mcg/dosage, 60 dosage
Serevent inh 25 mcg/dosage, 60 dosage
Foradil inh kap 12 mcg/dosage, 60 caps
Foradil inh 12 mcg/dosage, 50-100 dosage
Foradil combi 200 mcg
Foradil combi 400 mcg
Oxis turbuhaler 4.5-9 mcg/dosage, 60 dosage
Ventofor 12mg/60 inh.caps
Seretide disc 100-250-500 mcg/dosage 60 dosage
Symbicort 160/4.5 mcg/60-120 dosage, 320/9mcg/60 dosage

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
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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Zeynep Misirligil

Ankara Univ. Med. Fac, Chest Disease Dept

More Information

No publications provided

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

Keywords provided by AstraZeneca:

Symbicort
Turbuhaler
Persistent Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Salmeterol
Symbicort
Adrenergic beta-2 Receptor Agonists

Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012