Study In Asthma Control - Full Text View

Sponsor:	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 4

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

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

Intervention Details:

Other Name: salmeterol xinafoate/fluticasone propionate

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

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00273026 History of Changes
Other Study ID Numbers:	SFA103081
Study First Received:	January 5, 2006
Last Updated:	February 23, 2012
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Asthma Advair

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Albuterol
Fluticasone
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
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 24, 2012