A 12-Week Study in Adult Subjects With Asthma

The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary
outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ),
Nighttime awakenings and rescue medication usage.

Inclusion Criteria:

1. A signed and dated written informed consent form prior to the conduct of any study
procedures

2. Males and females between ≥ 18 and ≤ 60 years old.

3. Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more
than 10 pack-years (e.g., 1 pack [20 cigarettes] per day for 10 years).

6.Ability to understand and comply with the protocol requirements (including completion of
daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.

7.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the
screening visit. WOCBP include: any female who has experienced menarche and is not
post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not
undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal
ligation). Women who are using acceptable contraceptive medications or devices to prevent
pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be
considered WOCBP.

WOCBP must agree to avoid becoming pregnant for the duration of the study by using
adequate contraception at study entry and throughout the trial. Examples of adequate
contraception include the following:

- Norplant

- Medroxyprogesterone acetate injection

- Oral contraception

- Double-barrier method (e.g., condom and spermicide)

- Abstinence, with one of the above WOCBP will be advised to notify the Investigator of
any changes in their pregnancy status or any change in contraceptive use.

8.Agreement by subject to abide by the study protocol and its restrictions.

Exclusion Criteria:

1. Past or present disease, excluding asthma, which as judged by the investigator, may
place the subject at increased risk of complications, interfere with study
participation, or confound any of the study objectives These diseases include, but
are not limited to cardiovascular disease, malignancy, gastrointestinal disease,
hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease,
haematological disease, neurological disease, endocrine disease or pulmonary disease
(including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD,
eosinophilic bronchitis or pulmonary fibrosis).

2. An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to
Visit 2

3. A history of hypersensitivity to the study drug or its components, including
albuterol as rescue medication.

4. History of illegal drug or alcohol abuse within the past 5 years.

5. Pregnant or lactating women.

6. Use of > 8 inhalations per day of SABA on any two consecutive days from screening to
randomization (Visits 1 and 2).

7. Use of an investigational drug or device within 30 days prior to screening