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

Phase 2CompletedNCT00766090

GlaxoSmithKline190 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Asthma

Interventions

GW685698XDRUG

Inhaled Corticosteroid

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (16)

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period

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.

Time frame: Day 28 of the relevant treatment period (up to Study Day 112)

Secondary Outcomes

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods

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.

Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal

24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period

A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.

Time frame: Day 28 of the relevant treatment period (up to Study Day 112)

Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period

Data from ClinicalTrials.gov

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GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Cocoa, Florida, United States

GSK Investigational Site

Tallahassee, Florida, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Canton, Ohio, United States

...and 6 more locations

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.

Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period

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.

Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period

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.

Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)

Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods

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.

Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal