A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma

ovartis Pharma Services AG0 sites32 target enrollmentStarted: April 21, 2009Last updated: January 7, 2013

Conditions

Trial Snapshot

No summary available.

•1. Non smoker male and female adult patients aged 18-75 years inclusive, who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
•2. Patients with asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2008)
•3. Women of child-bearing potential (WOCBP), defined as all women physiologically
•capable of becoming pregnant, including women whose career, lifestyle, or sexual
•orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
•4. BMI must be within the range 18-32 kg/m2 (inclusive)
•5. Vital signs (after 3 minutes resting measured in the supine position) not considered by the Investigator to be indicative of a disorder which would make it unsafe for subject to participate in the study or require medical intervention.
•6. Able to communicate well with the investigator and comply with the requirements of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. A urine cotinine level greater then the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
•2. Patients who have had previous intubation for a severe asthma attack / exacerbation
•3. Patients who have had a severe asthma attack / exacerbation requiring hospitalization in the 6 months prior to screening.
•4. Patients who have had an emergency room visit for an asthma attack / exacerbation within 6 weeks prior to screening or any time between screening and per-dose day 1.
•5. Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and per-dose day 1
•6. Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
•7. Patients who require the use of =8 inhalations per day of the short-acting ß2-agonist (100 µg/90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from screening to randomization.
•8. Patients diagnosed with COPD as defined by the GOLD guidelines (2008).
•9. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active) or clinically significant bronchiectasis
•10. Any patient with lung cancer or a history of lung cancer

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