A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Concept1 device or as a PulmoSphere® formulation via the Simoon device

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

1. Male or 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 persistent 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 screening of =50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a
minimum of 48 hours for a long acting ß2-agonist.
c. Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value within 10-15 minutes after inhaling a total of 400 µg (4x100µg) of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting ß2-agonist.
3. BMI must be within the range 18-32 kg/m2 (inclusive)
4. 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.
5. 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

Exclusion Criteria

1. Women of child-bearing potential (WOCBP) - for exceptions see protocol
2. Male subjects and their partners who are not using two highly effective methods of contraception
3. Patients who have had previous intubation for a severe asthma attack / exacerbation.
4. Patients who have had a severe asthma attack / exacerbation requiring hospitalization in the 6 months prior to screening.
5. 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 Day -1 (Period 1).
6. Patients who have had a respiratory tract infection within 6 weeks prior to screening or any time between screening and pre-dose day 1.
7. Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
8. Patients with a known hypersensitivity to indacaterol or similar drugs.
9. 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 pre-screening.
10. Patients diagnosed with COPD as defined by the (GOLD Guidelines 2008).
11. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active) or clinically significant bronchiectasis.
12. Any patient with lung cancer or a history of lung cancer.
13. Participation in any clinical investigation within 4 weeks prior to dosing or longer if
required by local regulation. Previous participation in a study with either the
investigational or comparator drugs does not exclude a patient from participation in this study.
14. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
15. Significant illness within the two weeks prior to dosing.
16. History of left-ventricular heart failure or symptomatic coronary atherosclerotic
cardiovascular disease (ie, angina, history of MI).
17. A past medical history of life-threatening arrhythmias or a history, or family history, of long QT syndrome.
18. Patients with a persistent systemic blood pressure = 160/95 mmHg (whether treated or not), measured (in the dominant arm) on 2 separate occasions at least 24-hours apart.
19. Pregnant or nursing (lactating) women
20. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0% of total Hb measured at screening.
21. History of being immunocompromised, including a positive HIV (ELISA and Western blot) test result.
22. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
23. Patients who have ever received or are currently receiving treatment with omalizumab will not be allowed to participate in the study.
24. Treatments for asthma and allied conditions with listed compounds (see protocol)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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