A multi-centre, randomized, double-blind, placebocontrolled, 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 - ND

• Conditions: Persistent Asthma; MedDRA version: 12.0Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-010589-46-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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.
2) Patients with asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2008) and who additionally meet the following criteria:
a. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to screening.
b. Patients with an FEV1 at Visit 1 of ≥50% of the predicted normal value for the patient.
c. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 μg/180 μg of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test).
3) Women of child-bearing potential (WOCBP), unless they meet the definition of post-menopausal written in the Protocol OR have past 6 weeks from surgical bilateral oophorectomy OR are using one of the acceptable methods of contraception listed in the Protocol.
4) BMI must be within the range 18-32 kg/m2 (inclusive).
5) Vital signs 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.
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

Exclusion Criteria

1) A urine cotinine level greater then the local laboratory lowest level of quantification.
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 β2-agonist on any 2 consecutive days from screening to randomization.
8) Patients diagnosed with COPD.
9) Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis.
10) Any patient with lung cancer or a history of lung cancer.
11) Significant illness within the two weeks prior to dosing.
12) History of left-ventricular heart failure or symptomatic coronary atherosclerotic cardiovascular disease.
13) A past medical history of life-threatening arrhythmias or a history, or family history, of long QT syndrome.
14) Patients with a persistent systemic blood pressure ≥ 150/90 mmHg, measured on 2 separate occasions at least 24-hours apart.
15) Pregnant or nursing (lactating) women.
16) Patients with diabetes Type I or uncontrolled diabetes Type II.
17) Patients who have ever received or are currently receiving treatment with omalizumab.
18) Treatments for asthma and allied conditions with not allowed medicationslisted in the protocol prior to screening for at least the minimum period specified in the protocol or any time during the study.
19) The following treatments should not be used for the period specified in the protocol:
 antihistamines
 inhaled nasal cromolyn and inhaled nasal corticosteroids
 maintenance immuontherapy (desensitization) for allergies
 non-potassium-sparing diuretics
 β-adrenergic antagonists
 drugs with potential to significantly prolong the QT-interval
 tricyclic antidepressants and monoamine oxidase inhibitors
 anti-tussive medication
 opiates.
20) Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified