Efficacy and Safety Study in Subjects With Asthma
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00980200
First received: September 17, 2009
Last updated: November 8, 2012
Last verified: March 2011
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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:
- Mean clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of each 7-day treatment period. The trough FEV1 will be defined as the mean of the FEV1 values obtained at the last two scheduled timepoints at the Day 7 clinic visit. [ Time Frame: 11 and 12 hours after the morning BID dosing, or 23 and 24 hours after the evening QD dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Weighted mean for 24 hour serial FEV1 [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
| 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
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 |
| Last Updated: | November 8, 2012 |
| 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 May 19, 2013