Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma

This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical
trial design. During a screening epoch patient eligibility will be assessed. The screening
epoch will be followed by a 21-day Run-in epoch during which patients will continue their
inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting
bronchodilator-rescue medication. After the Run-in period patients will be randomized to one
of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment
period one is followed by a 10 to 14 days washout period after which patients begin the
second 7-day treatment period which is then followed by a second 10 to 14 days washout period
followed by the third 7-day treatment period. At the end of each treatment period spirometry
will be performed to assess the primary endpoint in terms of trough FEV1. The study
population will consist of approximately 144 patients with asthma who have been treated in a
stable regimen of ICS/LABA for at least 4 weeks prior to screening.

Inclusion Criteria:

- Male and female adult patients aged >= 18 or =< 65 years

- Patients with a diagnosis of asthma for a period of at least 1 year receiving daily
treatment of ICS/LABA in a stable regimen for >= 4 weeks

- Pre-bronchodilator FEV1 of >= 50% and =< 80% of the predicted normal value and an
increase in FEV1 of 12% and >= 200 ml during reversibility testing

Key Exclusion Criteria:

- Patients who have had an asthma exacerbation that required either treatment with
systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital
treatment within 6 weeks prior to screening and patients with a history of
life-threatening asthma attacks

- Patients who have had a respiratory tract infection within 4 weeks prior to screening.

- Patients who have smoked or inhaled tobacco products within the past 6 month of
screening.

- Patients with a history of chronic lung diseases other than asthma, including (but not
limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis,
interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is
confirmed as no longer active by imaging).

- Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3
months prior to Run-in who are expected to change therapy throughout the course of the
study.

- Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.

- Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or
perceived lack of efficacy).