Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
This study has been completed.
Sponsor:
Novartis
Collaborator:
Merck
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00605306
First received: January 18, 2008
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: indacaterol maleate / mometasone furoate Drug: placebo to indacaterol maleate/mometasone furoate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Mometasone furoate
Mometasone furoate monohydrate
Indacaterol
Indacaterol maleate
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Participants With Adverse Events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
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 Outcome Measures:
- Levels of Serum Potassium Over Time [ Time Frame: 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). ] [ Designated as safety issue: Yes ]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.
- Levels of Plasma Glucose Over Time [ Time Frame: 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). ] [ Designated as safety issue: Yes ]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.
- Levels of Serum Cortisol Over Time [ Time Frame: 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). ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 28 |
| Study Start Date: | January 2008 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: indacaterol maleate / mometasone furoate
Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
Other Name: QMF149
|
|
Placebo Comparator: 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.
|
Drug: placebo to indacaterol maleate/mometasone furoate
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605306
Locations
| France | |
| Novartis Investigator Site | |
| Neuil, France | |
| Novartis Investigator Site | |
| Paris, France | |
| Novartis Investigator Site | |
| Poitiers, France | |
Sponsors and Collaborators
Novartis
Merck
Investigators
| Principal Investigator: | NOVARTIS | Novartis investigator site |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00605306 History of Changes |
| Other Study ID Numbers: | CQMF149A2203 |
| Study First Received: | January 18, 2008 |
| Results First Received: | March 11, 2013 |
| Last Updated: | March 11, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Novartis:
|
Asthma spirometry lung function |
serum cortisol serum potassium plasma glucose |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Maleic acid Mometasone furoate Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013