Clinical trial NCT00980200: Efficacy and Safety Study in Subjects With Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: GW642444
once daily dosing
asthma
efficacy
safety
FEV1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Eligibility 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

Primary outcomes:
measure: 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:
measure: 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)
Other outcomes:
Locations:
city: Cypress
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Boerne
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trial. Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 Apr 19.