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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Participants With Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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^
- •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.
Arms & Interventions
indacaterol maleate/mometasone furoate
Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
Intervention: indacaterol maleate / mometasone furoate (Drug)
Placebo
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
Intervention: placebo to indacaterol maleate/mometasone furoate (Drug)
Outcomes
Primary Outcomes
Participants With Adverse Events
Time Frame: 15 days
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Secondary Outcomes
- Levels of Serum Potassium Over Time(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).)
- Levels of Plasma Glucose Over Time(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).)
- Levels of Serum Cortisol Over Time(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).)