Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605306
• Other study ID #: CQMF149A2203
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2008
• Last updated: March 11, 2013
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• indacaterol maleate / mometasone furoate
Indacaterol maleate / mometasone furoate 250/400 µg, 2 puffs once daily delivered via the Twisthaler device.
• placebo to indacaterol maleate/mometasone furoate
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Locations

Country	Name	City	State
France	Novartis Investigator Site	Neuil
France	Novartis Investigator Site	Paris
France	Novartis Investigator Site	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Adverse Events	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.	15 days	Yes
Secondary	Levels of Serum Potassium Over Time	At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.	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).	Yes
Secondary	Levels of Plasma Glucose Over Time	At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.	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).	Yes
Secondary	Levels of Serum Cortisol Over Time	At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.	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).	Yes