Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)

Inclusion Criteria

• •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
• •At Screening Visit, have sleep disturbance and scores of \>=2 on the interference with sleep rating scale (recall over the past 7 nights), and at least 30 on the Medical Outcomes Study Sleep scale (MOS-SS) Sleep Disturbance Sleep Scale (recall over the past 7 days)
• •At the Baseline Visit, must have sleep disturbance and scores of \>= 2 on interference with sleep rating scale (recorded in a diary during the past 7 nights), and at least 30 on the MOS-SS Sleep Problems Index II 9 items(SLP 9)