Last updated: 11/07/2018 05:52:30
Efficacy and Safety Study in Subjects with Asthma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-center, randomized, double-blind, placebo-controlled, five period cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of GW642444 administered via a novel dry powder inhaler (NDPI) in subjects ≥18 years of age with persistent asthma
Trial description: The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in trough (pre-bronchodilator and pre-dose) FEV1 on Day 7 of the treatment period
Timeframe: Baseline and Day 7 of the treatment period (up to Study Day 63)
Secondary outcomes:
Change from Baseline in weighted mean 24-hour FEV1 on Day 7 of the treatment period
Timeframe: Baseline and Day 7 of the treatment period (up to Study Day 63)
Interventions:
Drug: Dose 4 QD
Drug: Dose 3 QD
Drug: placebo
Drug: Dose 2 QD
Drug: Dose 1 BD
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
2010-04-01
Time perspective:
Not applicable
Clinical publications:
Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta2 agonist, vilanterol, in persistent asthma: a randomised trial. [Respir Med]. 2012;106(8):1110-1115.
Medical condition
Asthma
Product
vilanterol
Collaborators
Not applicable
Study date(s)
September 2009 to January 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Outpatient
- ≥18 years of age at Visit 1
- History of Life-Threatening Asthma
- No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient
- ≥18 years of age at Visit 1
- Male or Eligible Female
- Diagnosis of asthma at least 12 weeks prior to Visit 1
- Disease reversibility
- Current anti-asthma therapy
- Appropriately signed and dated informed consent has been obtained
- Able to comply with all the study requirements
Exclusion criteria:
- History of Life-Threatening Asthma
- No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
- No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
- Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
- History of severe milk protein allergy
- Non-compliance with study medication and other study-related requirements
- No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
- Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol
Trial location(s)
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Cypress, California, United States, 90630
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
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
2010-04-01
Actual study completion date
2010-04-01
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.
Additional information about the trial
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