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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo Inhalation Powder NDPI; Drug: Vilanterol; Drug: Salmeterol Inhalation Powder; Drug: Placebo Inhalation Powder Diskus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181895

112060

Details and patient eligibility

About

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.

Enrollment: 348 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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348 participants in 3 patient groups, including a placebo group

Vilanterol

Experimental group

Description:

Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks

Treatment:

Drug: Placebo Inhalation Powder Diskus

Drug: Vilanterol

Salmeterol

Active Comparator group

Description:

Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks

Treatment:

Drug: Salmeterol Inhalation Powder

Drug: Placebo Inhalation Powder NDPI

Placebo

Placebo Comparator group

Description:

Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks

Treatment:

Drug: Placebo Inhalation Powder Diskus

Drug: Placebo Inhalation Powder NDPI