A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
The purpose of this study is to assess the the ability of a single dose of LAS40468
 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®)
 administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety
 and tolerability of the treatments
This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the
 bronchodilation effect of a single dose of LAS40468 and a single dose of
 salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable
 asthma.

 The study will consist of a screening visit and treatment periods of approximately 13 hours
 separated by washout periods of 7 to 14 days from the time of Investigational Medicinal
 product (IMP) administration.
Inclusion Criteria:

 -  Adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both
 inclusive)

 -  Patients with a confirmed 6-months' history of asthma at the time of enrolment into
 the trial

 -  Patients treated with short-acting beta-agonists or inhaled corticosteroids at a
 stable dose and regimen (up to the equivalent of 1600 μg/day of beclometasone
 dipropionate) for at least 4 weeks prior to screening

 -  Patients whose (pre-salbutamol) forced expiratory volume in 1 second (FEV1) at
 screening is >60% of the predicted normal value after a washout of at least 6 hours
 for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if
 applicable

 -  Patients with a FEV1 absolute increase of at least 250 mL over baseline value after
 inhalation of 4 puffs of 100 μg of salbutamol in one of two pulmonary function tests
 performed within 10-15 min

 Exclusion Criteria:

 -  Patients with clinically significant respiratory or pulmonary diseases other than
 asthma or history of thoracic surgery

 -  Patients with a Body Mass Index (BMI) < 18 or > 40kg/m2 (both inclusive)