- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557466
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
December 12, 2012 updated by: Novartis
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® Device in Patients With COPD
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
568
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
- Novartis Investigator Site
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Rosario, Argentina
- Novartis Investigator Site
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Santillan, Argentina
- Novartis Investigator Site
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Liege, Belgium
- Novartis Investigator Site
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Santiago, Chile
- Novartis Investigator Site
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Santiago de Chile, Chile
- Novartis Investigator Site
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Val Pariso, Chile
- Novartis Investigator Site
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Bois-Guillaume, France
- Novartis Investigator Site
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Clermot Ferand, France
- Novartis Investigator Site
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Lille, France
- Novartis Investigator Site
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Marseille, France
- Novartis Investigator Site
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Nante, France
- Novartis Investigator Site
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Toulouse, France
- Novartis Investigator Site
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Berlin, Germany
- Novartis Investigator Site
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Bibertal, Germany
- Novartis Investigator Site
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Bochum, Germany
- Novartis Investigator Site
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Bonn, Germany
- Novartis Investigator Site - 2 sites
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Frankfurt, Germany
- Novartis Investigator Site
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Hamburg, Germany
- Novartis Investigator Site
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Heidelberg, Germany
- Novartis Investigator Site
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Koblenz, Germany
- Novartis Investigator Site
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Koln, Germany
- Novartis Investigator Site
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Marburg, Germany
- Novartis Investigator Site
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Solingen, Germany
- Novartis Investigator Site
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Budapest, Hungary
- Novartis Investigator Site
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Debrecen, Hungary
- Novartis Investigator Site
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Pecs, Hungary
- Novartis Investigator Site
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Dublin, Ireland
- Novartis Investigator Site
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Genova, Italy
- Novartis Investigator Site
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Napoli, Italy
- Novartis Investigator Site
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Pordenone, Italy
- Novartis Investigator Site
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Daugavpils, Latvia
- Novartis Investigator Site
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Riga, Latvia
- Novartis Investigator Site
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Kaunas, Lithuania
- Novartis Investigator Site
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Klaipeda, Lithuania
- Novartis Investigator Site
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Vilnius, Lithuania
- Novartis Investigator Site
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Tronheim, Norway
- Novartis Investigator Site
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Lima, Peru
- Novartis Investigator Site
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Izabelin, Poland
- Novartis Investigator Site
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Lodz, Poland
- Novartis Investigator Site
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Lublin, Poland
- Novartis Investigator Site
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Mrozy, Poland
- Novartis Investigator Site
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Olsztyn, Poland
- Novartis Investigator Site
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Rzeszow, Poland
- Novartis Investigator Site
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Wejhrowo, Poland
- Novartis Investigator Site
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Wloclawek, Poland
- Novartis Investigator Site
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Bucharest, Romania
- Novartis Investigator Site
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Bucuresti, Romania
- Novartis Investigator Site
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Cluj-napoca, Romania
- Novartis Investigator Site
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Iasi, Romania
- Novartis Investigator Site
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Timisoara, Romania
- Novartis Investigator Site
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Amanzimtoti, South Africa
- Novartis Investigator Site
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Bloemfontain, South Africa
- Novartis Investigator Site
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Bloemfontein, South Africa
- Novartis Investigator Site
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Cape Town, South Africa
- Novartis Investigator Site
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Durban, South Africa
- Novartis Investigator Site
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George, South Africa
- Novartis Investigator Site
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Johannesburg, South Africa
- Novartis Investigator Site
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Port Elizabeth, South Africa
- Novartis Investigator Site
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Pretoria, South Africa
- Novartis Investigator Site
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Tygerberg, South Africa
- Novartis Investigator Site
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Erzurum, Turkey
- Novartis Investigator Site
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Isparta, Turkey
- Novartis Investigator Site
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Istanbul, Turkey
- Novartis Investigator Site
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Kahramanmaras, Turkey
- Novartis Investigator Site
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Kayseri, Turkey
- Novartis Investigator Site
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Malatya, Turkey
- Novartis Investigator Site
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Manisa, Turkey
- Novartis Investigator Site
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Trabzon, Turkey
- Novartis Investigator Site
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Urfa, Turkey
- Novartis Investigator Site
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Belfast, United Kingdom
- Novartis Investigator Site
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Chesterfield, United Kingdom
- Novartis Investigator Site
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Glasgow, United Kingdom
- Novartis Investigator Site
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Plymouth, United Kingdom
- Novartis Investigator Site
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Warminster, United Kingdom
- Novartis Investigator Site
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Watford, United Kingdom
- Novartis Investigator Site
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Whitstable, United Kingdom
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
- Smoking history of at least 10 pack years
- Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%
Exclusion Criteria:
- Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
- Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
- Patients with a history of asthma.
- Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
- Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: indacaterol 62.5 μg
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: indacaterol 125 μg
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: Indacaterol 250 μg
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Experimental: indacaterol 500 μg
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Placebo AEROLIZER® device
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
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Active Comparator: formoterol
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
Placebo TWISTHALER® device
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Placebo Comparator: placebo
Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
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Placebo AEROLIZER® device
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Placebo TWISTHALER® device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline (prior to first dose) and Day 15 (24 hours after last dose)
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
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Baseline (prior to first dose) and Day 15 (24 hours after last dose)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
Time Frame: Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose.
The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
Time Frame: Day 1 Baseline (prior to first dose) and 24 hours post-dose.
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 1 Baseline (prior to first dose) and 24 hours post-dose.
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Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
Time Frame: Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose.
The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
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Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Time Frame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
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FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.
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Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
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Change From Baseline in Morning and Evening Peak Expiratory Flow
Time Frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period).
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The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling.
Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study.
Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
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Baseline (recorded during the screening period) and Days 1-14 (treatment period).
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Number of Participants Using Rescue Medication
Time Frame: Over 14 days
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Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
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Over 14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
December 12, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- CQMF149B2201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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