pharmacodynamics, safety, tolerability, and pharmacokinetics of two orally inhaled indacaterol salts in adult subjects with asthma.

Conditions: Asthma

Summary: this study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.

this is a randomized, double-blind, placebo-controlled, three-period cross-over study in asthma patients. the study will consist of a screening epoch, followed by a treatment epoch which consists of three treatment periods, and will conclude with an end of study epoch. each subject will be assigned to 1 of 6 treatment sequences and will sequentially receive the investigational products and placebo during the trial.

Eligibility criteria:
key inclusion criteria: * male and female patients aged ≥ 18 and above * patients with a documented physician diagnosis of asthma for a period of at least 1 year prior to screening and who additionally meet the following criteria: patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks prior to screening. * pre-bronchodilator fev1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient during screening. * patients who demonstrate an increase in fev1 of ≥ 12% and ≥ 200 ml after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at screening. * subjects must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (bmi) within the range of 18 to 40 kg/m2. key exclusion criteria: -contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: sympathomimetic amines / adrenoceptor agonist agents lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption) * patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of screening. * patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to screening. * patients with a history of chronic lung diseases other than asthma * patients who have a decline in pef from the reference pef (taken at screening) of ≥30% for 5 of 6 consecutive scheduled pef readings (readings taken at morning and evening) during at least 3 days of screening epoch prior to randomization. * patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) during screening prior to randomization. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test. * patients with type i diabetes or uncontrolled type ii diabetes (hba1c \> 9%) at screening. * current smokers (urine cotinine \> than the laboratory's lowest level of quantification (loq of 500 ng/ml or lower)) and patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.).

Keywords: asthma, asthma attack, difficulty breathing, bronchial diseases, lung, lung diseases, inhaled drugs, bronchodilator, inhaled corticosteriod