Clinical trial NCT00927901: Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: QAB149
asthma
indacaterol salts (acetate, maleate, and xinafoate)
orally inhaled indacaterol salts
persistent asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
timeFrame: Baseline to the end of each treatment period (Day 7)
Secondary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
timeFrame: Baseline to Day 1
measure: Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
timeFrame: Day 1 and Day 7
measure: Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
timeFrame: Baseline to the end of each treatment period (Day 7)
measure: Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
timeFrame: End of each treatment period (Day 7)
measure: Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
timeFrame: End of each treatment period (Day 7)
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Verona
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: