Last updated: 11/07/2018 04:23:14
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents with Persistent Asthma
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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 persistent asthma in adults and adolescents uncontrolled on inhaled corticosteroids
Trial description: The objective of this study is to evaluate the efficacy and safety of vilanterol inhalationpowder administered once daily in the evening in adolescent and adult subjects 12years of age and older with persistent asthma over a 12-week treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in weighted-mean 24-hour serial forced expiratory volume in one second (FEV1) at Week 12
Timeframe: Baseline and Week 12
Secondary outcomes:
Change from Baseline in the percentage of rescue-free 24-hour (hr) periods during the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in individual serial FEV1 assessments at the end of the 12-week treatment period, including the 12-hour and 24-hour time points
Timeframe: Baseline and Week 12
Change from Baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM (evening) Peak Expiratory Flow (PEF) averaged over the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in daily AM (morning) PEF averaged over the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Number of participants with the indicated time to an increase of >=12% and >=200 milliliters (mL) above Baseline in FEV1 on Day 1 and Day 84 (0-2 hours)
Timeframe: Day 1 and Week 12
Number of participants with the indicated Global Assessment of Change questionnaire responses at the end of Week 4 and Week 12
Timeframe: Week 4 and Week 12
Interventions:
Drug: Vilanterol
Drug: Salmeterol Inhalation Powder
Drug: Placebo Inhalation Powder NDPI
Drug: Placebo Inhalation Powder Diskus
Enrollment:
348
Observational study model:
Not applicable
Primary completion date:
2011-26-08
Time perspective:
Not applicable
Clinical publications:
Lötvall J, Bateman ED, Busse WW, O’Byrne PM, Woodcock A, Toler WT, Jacques L, Goldfrad C, Bleecker ER.Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids.J Negat Results Biomed.2014;13:9doi: 10.1186/1477-5751-13-9
Medical condition
Asthma
Product
salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2010 to August 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Clinton, South Carolina, United States, 29325
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chester, South Carolina, United States, 29706
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30046
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-26-08
Actual study completion date
2011-26-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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