This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study
evaluating Asmanex Twisthaler 220 mcg once daily (QD) PM compared with "Asmanex" Placebo QD
PM for 12 weeks. Efficacy will be measured for the changes in FEV1 from Baseline to the end
of treatment period (Week 12 or end of the study).
Inclusion Criteria:
- Subjects must demonstrate their willingness to participate in the study and comply
with its procedures by signing a written informed consent.
- Must be 18-75 years of age, of either sex and any race.
- Must have a diagnosis of asthma for >= 12 months.
- Must be considered as having mild persistent or moderate persistent asthma.
- Prior to Screening subjects must be using either low or moderate doses of an inhaled
corticosteroid (ICS), with a short-acting beta-2 agonist (SABA) as needed (prn), or a
SABA as necessary as monotherapy, for asthma control. Subjects who are using a
combination ICS plus long-acting beta-2 agonist (LABA) medication, such as Advair
100/50, must be changed to treatment with fluticasone propionate (FLOVENT HFA 110 mcg
twice daily [BID]) at least 30 days prior to the start of Run-In Period. Subjects who
are using LABA as monotherapy must be switched to SABA prn for at least 5 days prior
to the start of Run-In Period.
- If the subject had been using a leukotriene receptor antagonist (LTRA), he/she must be
off treatment with the LTRA for at least 14 days prior to the Baseline Visit.
- Must have an FEV1 >= 65% but <= 85% of predicted normal value at Visit 1 (Screening
Visit) and at Visit 3 (Baseline Visit) when SABAs have been withheld for at least 6
hours.
- Must demonstrate an increase of absolute FEV1 of >= 12% with an absolute volume
increase of at least 200 mL at the Screening Visit or have documentation of FEV1
reversibility of >= 12% within 2 years prior to the Screening Visit. FEV1
reversibility testing should be done after withholding inhaled SABA medication for at
least 6 hours.
- Subjects must have a frequency of asthma score of at least 3 (at least 2 symptoms);
frequency of bronchodilator use score of at least 3 at the Screening Visit.
- Must have a TASS of at least 6 on 8 or more of the 15 AM and PM recordings during the
7 day Run-in period and the AM of the Baseline Visit (Visit 3).
- At the Screening Visit, subjects must complain of sleep disturbance and must have: a)
a score of >= 2 on the interference with sleep rating scale (recall over the past 7
days/ >= 1 night) and b) a score at least 30 on the MOS-SS Sleep Disturbance Sleep
Scale (recall over the past 7 days).
- At the Baseline Visit, subjects must complain of sleep disturbance and must have: a) a
score of >= 2 on interference with sleep rating scale (recorded in a diary during the
7 day Run-In Period/ >= 1 night) and b) a score of at least 30 on the MOS-SS Sleep
Problems Index II (SLP 9) and at least 30 on the Daytime Somnolence Sleep Scale.
Exclusion Criteria:
- Is a female who is pregnant, or intends to become pregnant during the study.
- Is nursing, or intends to be nursing during the study or within 30 days after study
completion.
- Has participated in any clinical trial within the last 30 days or in a clinical trail
that involved antibodies for asthma or rhinitis within 3 months prior to Randomization
(Visit 3).
- Has had an unscheduled physician or clinic visit (due to exacerbation of asthma)
within 1 month prior to Randomization (Visit 3).
- Has 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 Randomization (Visit
3).
- Has 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 Randomization (Visit 3).
- Required more than 2 courses of oral/systemic corticosteroids for asthma control
within 12 months prior to Randomization (Visit 3).
- Has a history of sleep disorders, including narcolepsy, insomnia, daytime somnolence,
or use of medications that affect alertness or sleep.
- Has sleep apnea, obstructive sleep apnea-hypopnea syndrome, or is being treated with
CPAP or Bi-PAP, or is receiving oxygen by inhalation day or night.
- Is allergic to corticosteroids, SABAs, or LABAs.
- Required ventilator support for respiratory failure secondary to their asthma within
the last 10 years.
- Has symptomatic allergic rhinitis (total nasal and non-nasal symptom severity score >=
4) noted at the Screening and Baseline Visits (Visits 1, 2, and 3). (During any
phase of the study, subjects who become symptomatic with allergic rhinitis can be
treated with a nonsedating antihistamine and/or inhaled nasal corticosteroid.
Allergic rhinitis severity should be rated and the score recorded in the diary at the
initiation of this illness.
- nasal signs/symptoms include nasal congestion/stuffiness, rhinorrhea, nasal
itching, sneezing; non-nasal signs/symptoms include eye tearing, eye itching, eye
redness, itching ears (palate); severity rating: 0 = none to 3 = severe
- Has a Body-Mass-Index (BMI) greater than 35.
