A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via Twisthaler in Adult and Adolescent Patients With Persistent Asthma
This study has been completed.
Sponsor:
Novartis
Collaborator:
Schering-Plough
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00545272
First received: October 16, 2007
Last updated: April 6, 2009
Last verified: April 2009
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Purpose
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered in Twisthaler .
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Indacaterol Drug: formoterol Drug: placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | A Randomized, Multi-Center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via Twisthaler in Adult and Adolescent Patients With Persistent Asthma |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- The mean change from baseline to 24 hr post-dose of (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Standardized FEV1 area under the curve (AUC) between baseline (predose) and 4 hours post-dose [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
- Morning and evening peak expiratory flow [ Time Frame: Over 14 days ] [ Designated as safety issue: No ]
- Rescue medication use [ Time Frame: Over 14 days ] [ Designated as safety issue: No ]
Enrollment: | 392 |
Study Start Date: | October 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
Indacaterol Twisthaler 62.50 μg o.d. + placebo Aerolizer
|
Drug: Indacaterol |
Active Comparator: 2
Indacaterol Twisthaler 125 μg o.d. + placebo Aerolizer
|
Drug: Indacaterol |
Active Comparator: 3
Indacaterol Twisthaler 250 μg o.d. + placebo Aerolizer
|
Drug: Indacaterol |
Active Comparator: 4
Indacaterol Twisthaler 500 μg o.d. + placebo Aerolizer
|
Drug: Indacaterol |
Active Comparator: 5
Formoterol Aerolizer 12 μg b.i.d. + placebo Aerolizer
|
Drug: formoterol |
Placebo Comparator: 6
placebo twisthaler and placebo aerolizer
|
Drug: placebo |
Eligibility
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or IRB/IEC/REB approval), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient's parent / guardian.
Patients with asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:
- Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
- Patients with an FEV1 at Visit 1 of ≥50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
- Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180 µg of salbutamol/albuterol metered dose inhaler (MDI) (or equivalent dose of dry powder inhaler [DPI]) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
Exclusion Criteria:
- Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
- Patients with chronic obstructive pulmonary disease (COPD), or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients:
- who's asthma is likely to deteriorate during the study (including seasonal allergy),
- hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1,
- who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1
- who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1
- Patients who require the use of ≥8 inhalations per day of short acting B2-agonist (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from Screening to Randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545272
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Show 60 Study Locations
Sponsors and Collaborators
Novartis
Schering-Plough
Investigators
Study Chair: | Novartis Pharma | Novartis Pharmaceuticals |
More Information
No publications provided
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | external affairs, Novartis |
ClinicalTrials.gov Identifier: | NCT00545272 History of Changes |
Other Study ID Numbers: | CQMF149A2201 |
Study First Received: | October 16, 2007 |
Last Updated: | April 6, 2009 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Israel: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health and Social Development of the Russian Federation Spain: Spanish Agency of Medicines South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
QMF indacaterol Twisthaler |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012