A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group,
 repeated-dose study in male and female patients with moderate to severe asthma in which
 patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will
 be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease
 the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared
 to placebo. Incidence of asthma exacerbation is the primary endpoint.
Inclusion Criteria:

 1. Male or female patient, ≥ 18 years of age with a documented clinical history of
 asthma, has been treated for asthma and, in the opinion of the Investigator, is not
 fully controlled on current asthma therapy.

 2. Patient satisfies, or has satisfied in the past, the GINA definition of moderate
 persistent to severe persistent asthma.

 3. Patient has been maintained on moderate-to-high doses of ICS and LABA in the form of
 combination therapy or as individual agents (equivalent to fluticasone ≥ 250 mcg bid
 and salmeterol ≥ 50 mcg bid for ≥ 4 weeks before Screening [Visit 1]).

 4. Patient has experienced an asthma exacerbation at least once in the past 2 years
 (defined here as use of physician prescribed oral corticosteroids or asthma requiring
 treatment increase approximately 4 times the baseline dose of inhaled corticosteroids
 or hospitalization due to asthma).

 5. Patient has a pre-bronchodilator FEV1 ≥ 50% but ≤ 95% of the predicted value at both
 Screening (Visit 1) and Visit 2.

 6. Patient demonstrates ≥ 12% reversibility (and a ≥ 200 mL difference) from
 prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 4 puffs of a
 short-acting beta-agonist at Screening (Visit 1) or has ≥ 10% reversibility from
 pre-bronchodilator FEV1 plus a documented reversibility of ≥ 12% within the previous
 12 months (documented methacholine or histamine sensitivity (PC20) <8mg/mL is also
 acceptable evidence or reversible airways disease).

 7. Patient scores ≤ 20 on The Asthma Control Test™ at Screening (Visit 1) and Visit 2.

 8. Female patient of childbearing potential or male patient and his female partner are
 practicing adequate and effective forms of contraception and agree to continue for the
 duration of the study. If female, must have a negative urine pregnancy test.

 9. Patient has a pre-study medical history, physical examination, 12-Lead ECG, and safety
 laboratory test results within normal reference ranges or clinically acceptable to the
 Investigator.

 10. Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a <
 10 pack/year history of smoking.

 11. Patient is medically stable for at least 8 weeks before Randomization (Visit 2), and
 the Investigator does not consider study participation to place the patient at
 increased risk of AEs (with the exception of possible asthma exacerbations).

 12. Patient is able and willing to give written informed consent.

 Exclusion Criteria:

 1. Patient has a current diagnosis of respiratory disorder other than asthma (e.g.,
 chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary disease
 [COPD], etc).

 2. Patient has received oral corticosteroid treatment within 8 weeks of Randomization
 (Visit 2)or patient has been intubated for ventilation in the past 5 years.

 3. Patient has used any leukotriene antagonist within 1 week before Screening (Visit 1)
 or anti-IgE medications within 4 weeks of Screening (Visit 1).

 4. Female patient is pregnant, breastfeeding, or not using an adequate method of
 contraception.

 5. Patient has a clinically relevant medical history of very severs asthma that would
 preclude steroid reduction or sufficient compliance with the protocol.

 6. Patient uses concomitant medications, including herbal, over-the-counter, or
 prescription medicines that, in the opinion of the Investigator, may affect the
 outcome of study endpoints and/or well-being of the patient.

 7. Patient has a history of alcohol or substance abuse within 2 years of Screening (Visit
 1).

 8. Patient consumes more than 28 units (male) or 21 units (female) of alcohol a week
 (unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of beer).

 9. Patient cannot communicate reliably with the Investigator or is unlikely to cooperate
 with the requirements of the study.

 10. Patient has previously taken AEROVANT™ or another formulation of AER 001 (e.g., BAY
 16-9996, pitrakinra).

 11. Patient has participated in any clinical trial involving use of an investigational
 drug within 12 weeks of first dose of study drug.