Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00766090
First received: October 2, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to compare once and twice daily GW685698 in asthma


Condition Intervention Phase
Asthma
Drug: GW685698X
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-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period [ Time Frame: Day 28 of the relevant treatment period (up to Study Day 112) ] [ 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. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.


Secondary Outcome Measures:
  • Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods [ Time Frame: From the first dose of the study medication up to Week 16/Early Withdrawal ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.

  • 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period [ Time Frame: Day 28 of the relevant treatment period (up to Study Day 112) ] [ Designated as safety issue: No ]
    A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.

  • Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period [ Time Frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) ] [ Designated as safety issue: No ]
    Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

  • Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period [ Time Frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) ] [ Designated as safety issue: No ]
    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

  • Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period [ Time Frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) ] [ Designated as safety issue: No ]
    Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

  • Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods [ Time Frame: From the first dose of the study medication up to Week 16/Early Withdrawal ] [ Designated as safety issue: No ]
    Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.


Enrollment: 190
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW685698X Drug: GW685698X
Inhaled Corticosteroid

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Clinical diagnosis of Asthma
  • Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
  • FEV1 between 40-85% predicted
  • Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

  • History of life threatening asthma
  • Respiratory Infection or oropharyngeal candidiasis
  • Asthma exacerbation
  • Uncontrolled disease or clinical abnormality
  • Allergies
  • Taking another Investigational medications or other prohibited medications
  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: NCT00766090

Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Torrance, California, United States, 90505
United States, Florida
GSK Investigational Site
Cocoa, Florida, United States, 32927
GSK Investigational Site
Tallahassee, Florida, United States, 32308
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
GSK Investigational Site
Rolla, Missouri, United States, 65401
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
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
Austin, Texas, United States, 78750
GSK Investigational Site
Boerne, Texas, United States, 78006
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Waco, Texas, United States, 76712
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: NCT00766090     History of Changes
Other Study ID Numbers: 112202
Study First Received: October 2, 2008
Results First Received: June 6, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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 August 19, 2014