Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/8/2017
Start Date:April 3, 2012
End Date:February 4, 2013

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A Multi-center, Randomized, Double-blind, Dose-ranging Study to Evaluate GSK573719 in Combination With Fluticasone Furoate, Fluticasone Furoate Alone, and an Active Control of Fluticasone Furoate/Vilanterol Combination in Subjects With Asthma

Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in
combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled
Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic
bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms
on large and small airways. Most of the experience with older anti-cholinergics had been with
acute use and little is known about their effect in chronic use in asthma. This is a
multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled
GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and
Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each
eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3
treatment periods per subject. The total duration of subject participation is approximately
14 weeks.


Inclusion Criteria:

- Outpatient

- 18 years of age or older at Visit 1

- Diagnosis of Asthma

- Male or eligible Female

- Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1

- Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes following
albuterol at Visit 1

- A need for regular controller therapy (i.e., inhaled corticosteroids alone or in
combination with a long‐acting beta‐agonist, or leukotriene modifier etc.,) for a
minimum of 8 weeks prior to Visit 1.

Exclusion Criteria:

- History of Life threatening asthma

- Respiratory infection not resolved

- Asthma exacerbation

- Concurrent respiratory disease

- Current Smokers

- Other diseases that are uncontrolled disease or disease state that, in the opinion of
the investigator, would put the safety of the patient at risk through study
participation or would confound the interpretation of the efficacy results if the
condition/disease exacerbated during the study

- A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV

- Visual clinical evidence of oropharyngeal candidiasis

- Drug or milk protein allergies

- Concomitant medications affecting course of asthma

- Use of any other investigational medication within 30 days or 5 drug half-lives
(whichever is longer)

- Previous use of GSK573719

- Any disease preventing use of anticholinergics

- Any condition that impairs compliance with study protocol including visit schedule and
completion of daily diaries

- Any subject with a history of alcohol or substance abuse

- Any affiliation with Investigator's site
We found this trial at
5
sites
Medford, Oregon 97504
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Medford, OR
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Buenos Aires,
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Buenos Aires,
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Orangeburg, South Carolina 29118
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Orangeburg, SC
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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