A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus "Asmanex" Placebo QD PM
概览
- 阶段
- 4 期
- 干预措施
- Asmanex twisthaler
- 疾病 / 适应症
- Asthma
- 发起方
- Organon and Co
- 入组人数
- 26
- 主要终点
- Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
- 状态
- 终止
- 最后更新
- 4年前
概览
简要总结
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).
研究者
入排标准
入选标准
- •Sign informed consent
- •Be 18-75 years of age, of either sex and any race
- •Have asthma for \>= 12 months
- •Have mild or moderate persistent asthma
- •Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period
- •Be off treatment with leukotriene receptor antagonist (LTRA) for at least 14 days prior to Screening
- •Have an FEV1 \>=65% but \<=85% of predicted normal value at Screening and at Baseline when SABAs have been withheld for at least 6 hours
- •Demonstrate an increase of absolute FEV1 of \>= 12% with an absolute volume increase of at least 200mL during Screening. Written documentation of FEV1 reversibility of \>= 12% within 2 years prior to Screening was acceptable in lieu of testing. FEV1 reversibility testing should be done after withholding inhaled SABA for at least 6 hours
- •Have a frequency of asthma score of at least 2 (at least 2 symptoms) and/or frequency of bronchodilator use score of at least 2 at Screening
- •Have a Total Asthma Severity Score (TASS) of at least 4 on 8 or more of the AM and PM recordings from the last 7 days during the Run-in period prior to Baseline and the AM of the Baseline Visit
排除标准
- 未提供
研究组 & 干预措施
Asmanex Twisthaler
干预措施: Asmanex twisthaler
Placebo inhaler
干预措施: Placebo for Asmanex twisthaler
结局指标
主要结局
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
时间窗: Twelve (12) weeks
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.