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

NCT00605306 | Completed Phase 2 Results

• 1 other identifier: CQMF149A2203
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

Asthma; spirometry; lung function; serum cortisol; serum potassium; plasma glucose

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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).

Study Arms (2)

indacaterol maleate/mometasone furoate

EXPERIMENTAL

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.

Drug: indacaterol maleate / mometasone furoate

Placebo

PLACEBO COMPARATOR

Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.

Drug: placebo to indacaterol maleate/mometasone furoate

Interventions

indacaterol maleate / mometasone furoate DRUG

Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.

Also known as: QMF149

indacaterol maleate/mometasone furoate

placebo to indacaterol maleate/mometasone furoate DRUG

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Novartis Investigator Site

Neuil, France

Location

Novartis Investigator Site

Paris, France

Location

Novartis Investigator Site

Poitiers, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; QMF149

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• NOVARTIS

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 22, 2013
• Results First Posted: April 22, 2013

Record last verified: 2013-03

Locations

FR (3)