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

 Exclusion Criteria

 -  Women who are pregnant or intend to become pregnant during the study

 -  Women who are nursing or intend to nurse during the study or within 30 days after
 completion

 -  Have participated in any clinical trial within the last 30 days or in one involving
 antibodies for asthma or rhinitis within 3 months prior to Screening

 -  Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month
 prior to Screening

 -  Have been treated in the emergency room or admitted to the hospital due to
 exacerbation of asthma on two or more occasions within the 12 months prior to
 Screening

 -  Have used >12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist
 per day on 2 consecutive days within 4 weeks prior to Screening

 -  Required more than 2 courses of oral/systemic corticosteroids for asthma within 12
 months prior to Screening

 -  Have a history of sleep disorders, including narcolepsy, or use of medications that
 affect alertness or sleep

 -  Have sleep apnea, obstructive sleep apnea-hypopnea, or are being treated with the
 ventilation devices Continuous Positive Airway Pressure (CPAP) or (Bi-level Positive
 Airway Pressure (Bi-PAP), or are receiving oxygen by inhalation

 -  Are smokers or ex-smokers who have smoked within 6 months prior to

 Screening or have a cumulative smoking history of 10 pack-years or greater

 -  Are allergic to corticosteroids, SABAs, or LABAs

 -  Required ventilator support for respiratory failure secondary to asthma in the last 10
 years

 -  Have a Body-Mass-Index greater than 35