Clinical trial NCT00605306: Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
spirometry
lung function
serum cortisol
serum potassium
plasma glucose
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.


Eligibility criteria: Inclusion Criteria:

* Male and female adult patients aged 18-65 years (inclusive)
* Patients with mild-moderate asthma
* Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
* Body mass index (BMI) must be within the range of 18-32 kg/m\^2.
* Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.

Exclusion Criteria:

* Patients who suffer from chronic obstructive pulmonary disease (COPD)
* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
* QTcF interval \> 450 msec in men and \>470 msec in women
* Pregnant women or nursing mothers
* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
* History of immunocompromise, including a positive human immunodeficiency virus (HIV)
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within 12 months of dosing

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Participants With Adverse Events
timeFrame: 15 days
Secondary outcomes:
measure: Levels of Serum Potassium Over Time
timeFrame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
measure: Levels of Plasma Glucose Over Time
timeFrame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
measure: Levels of Serum Cortisol Over Time
timeFrame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Other outcomes:
Locations:
city: Neuil
country: France
facility: Novartis Investigator Site
city: Paris
country: France
facility: Novartis Investigator Site
city: Poitiers
country: France
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References: