Status:
COMPLETED
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Patients with asthma, receiving daily treatment with inhaled corticosteroid.
- Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range 18-32 kg/m\^2 (inclusive).
- Able to communicate well with the investigator and comply with the requirements of the study.
- Exclusion criteria:
- A urine cotinine level greater than the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
- Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening.
- 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 pre-dose on day 1 of the study.
- Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
- Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler \[MDI\] or equivalent dose of a dry-powder inhaler \[DPI\]) on any 2 consecutive days from screening to randomization.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2008).
- 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.
- Significant illness.
- History of being immunocompromised, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot).
- A positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
- Patients who are considered vulnerable as per ICH GCP guidelines.
- Patients with a history of hypersensitivity to indacaterol or to similar drugs including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- Treatments for asthma and allied conditions:
- The following treatments should not be used unless they have been stabilized prior to screening: antihistamines, inhaled nasal cromolyn, inhaled nasal corticosteroids, and maintenance immunotherapy.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00927901
Start Date
June 1 2009
End Date
November 1 2009
Last Update
September 9 2013
Active Locations (3)
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1
Novartis Investigative Site
Poitiers, France
2
Novartis Investigative Site
Wiesbaden, Germany
3
Novartis Investigative Site
Verona, Italy