Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Condition: Asthma
MeSH terms: Asthma
Intervention: Asmanex twisthaler; Placebo for Asmanex twisthaler
Intervention description: Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks; Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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