Efficacy and Safety Study in Subjects With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00980200
First received: September 17, 2009
Last updated: August 29, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Dose 4 QD
Drug: Dose 3 QD
Drug: placebo
Drug: Dose 2 QD
Drug: Dose 1 BD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period [ Time Frame: Baseline and Day 7 of the treatment period (up to Study Day 63) ] [ Designated as safety issue: No ]
    Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.


Secondary Outcome Measures:
  • Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period [ Time Frame: Baseline and Day 7 of the treatment period (up to Study Day 63) ] [ Designated as safety issue: No ]
    Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.


Enrollment: 75
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C/E/A/B/D
GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD
Drug: Dose 2 QD
QD once daily
Experimental: D/C/E/A/B
GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD
Drug: Dose 3 QD
QD once daily
Experimental: A/B/C/D/E
placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD
Drug: placebo
placebo
Experimental: B/A/D/E/C
GW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD
Drug: Dose 1 BD
BD twice daily
Experimental: E/D/B/C/A
GW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo
Drug: Dose 4 QD
QD once daily

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980200

Locations
United States, California
GSK Investigational Site
Cypress, California, United States, 90630
GSK Investigational Site
Huntington Beach, California, United States, 92647
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
GSK Investigational Site
Boerne, Texas, United States, 78006
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00980200     History of Changes
Other Study ID Numbers: 113310
Study First Received: September 17, 2009
Results First Received: June 6, 2013
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW642444
once daily dosing
asthma
efficacy
safety
FEV1

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014