Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma - Full Text View

Purpose

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Condition	Intervention	Phase
Asthma	Drug: Vilanterol Drug: Salmeterol Inhalation Powder Drug: Placebo Inhalation Powder NDPI Drug: Placebo Inhalation Powder Diskus	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistentasthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in weighted mean serial FEV1 over 0-24 hours post-dose at the end of the 12-week treatment period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nominated Powered: Change from baseline in the percentage of rescue-free, 24-hour periods during the 12-week treatment period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in the percentage of symptom-free, 24-hour periods during the 12-week treatment period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in individual serial FEV1 assessments at the end of the 12-week assessment period including the 12- and 24-hour time points [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM Peak Expiratory Flow averaged over the 12-week period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in daily AM Peak Expiratory Flow averaged over the 12-week period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Time to an increase of ≥12% and ≥200ml above baseline in FEV1 on Day 1 and Day 84 (0-2 hours) [ Time Frame: Day 1 and on Day 84 ] [ Designated as safety issue: No ]
Global Assessment of Change: assesses asthma symptom change (improve, same, worse) and rescue use (more, same, less) [ Time Frame: Baseline, 4 week, and 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	348
Study Start Date:	September 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vilanterol Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks	Drug: Vilanterol Vilanterol inhalation powder inhaled orally once daily for 12 weeks Drug: Placebo Inhalation Powder Diskus Placebo inhalation powder inhaled orally twice daily for 12 weeks
Active Comparator: Salmeterol Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks	Drug: Salmeterol Inhalation Powder Salmeterol inhalation powder inhaled orally twice daily for 12 weeks Drug: Placebo Inhalation Powder NDPI Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Placebo Comparator: Placebo Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks	Drug: Placebo Inhalation Powder NDPI Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler Drug: Placebo Inhalation Powder Diskus Placebo inhalation powder inhaled orally twice daily for 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Outpatient at least 12 years of age
Both genders; females of childbearing potential must be willing to use birth control method
Clinical diagnosis of asthma for ≥12 weeks
Best pre-bronchodilator FEV1 of 40%-90% predicted
Reversibility of FEV1 of at least 12% and 200mls
Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits

Exclusion Criteria:

History of life-threatening asthma
Respiratory infection within last 4 weeks leading to change in asthma management
Asthma exacerbation within last 3 months
Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
Allergies to study drugs, study drugs' excipients, or medications related to study drugs
Taking another investigational medication or medication prohibited for use during the study.
Previous participation in a vilanterol (GW642444) study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181895

Show 33 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01181895 History of Changes
Other Study ID Numbers:	112060
Study First Received:	July 15, 2010
Last Updated:	September 13, 2012
Health Authority:	Peru: Instituto Nacional de Salud Mexico: Ministry of Health - Secretaria de Salud - Comisión de Autorización Sanitaria - Comisión Federal para la Protección cotnra riesgos de salud Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Ukraine: State Pharmacological Center of Ministry of Health of Ukraine Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
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 May 21, 2013