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

This is an interventional treatment trial for Asthma Read More

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