Study In Asthma Control - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00273026

Purpose

This study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks.

Condition	Intervention	Phase
Asthma	Drug: salmeterol xinafoate/fluticasone propionate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	An Open-Label, Multi-Centre, Randomized, Parallel Group Clinical Effectiveness Study to Determine the Level of Asthma Control in Adolescent and Adult Patients With ADVAIR Versus Usual Care for 24 Weeks.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of patients achieving well-controlled asthma at the end of the treatment period.

Secondary Outcome Measures:

Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.

Estimated Enrollment:	680
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

documented clinical history of asthma and receiving regular maintenance therapy.

Exclusion Criteria:

Using oral/parenteral or depot corticosteroids within 12 weeks of visit 1.
History of heavy smoking or substance abuse.
Females who are pregnant or lactating.
Required emergency room treatment for their asthma 12 weeks prior to Visit 1.
Serious, uncontrolled, systemic disease that may make study participation unsafe or inappropriate in the opinion of the physician.
Other medical criteria will be evaluated at the screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273026

Show 127 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SFA103081
Study First Received:	January 5, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00273026 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Asthma Advair

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Albuterol
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents

Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Therapeutic Uses

Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 01, 2009