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A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT00557466
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Novartis

Brief Summary:
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Condition or disease Intervention/treatment Phase
COPD Drug: indacaterol Drug: formoterol Drug: placebo to indacaterol Drug: placebo to formoterol Drug: short acting β2- agonist Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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® Device in Patients With COPD
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Drug: placebo to formoterol
Placebo AEROLIZER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Drug: placebo to formoterol
Placebo AEROLIZER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Drug: placebo to formoterol
Placebo AEROLIZER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Drug: placebo to formoterol
Placebo AEROLIZER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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.
Drug: formoterol
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

Drug: placebo to indacaterol
Placebo TWISTHALER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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.
Drug: placebo to indacaterol
Placebo TWISTHALER® device

Drug: placebo to formoterol
Placebo AEROLIZER® device

Drug: short acting β2- agonist
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.

  3. 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. ]
    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.

  4. 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 ]
    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.

  5. Change From Baseline in Morning and Evening Peak Expiratory Flow [ Time Frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period). ]
    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.

  6. Number of Participants Using Rescue Medication [ Time Frame: Over 14 days ]
    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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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557466


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Locations
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Argentina
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Buenos Aires, Argentina
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Rosario, Argentina
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Santillan, Argentina
Belgium
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Liege, Belgium
Chile
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Santiago de Chile, Chile
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Santiago, Chile
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Val Pariso, Chile
France
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Bois-Guillaume, France
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Clermot Ferand, France
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Lille, France
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Marseille, France
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Nante, France
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Toulouse, France
Germany
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Berlin, Germany
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Bibertal, Germany
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Bochum, Germany
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Bonn, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Koblenz, Germany
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Koln, Germany
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Marburg, Germany
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Solingen, Germany
Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Pecs, Hungary
Ireland
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Dublin, Ireland
Italy
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Genova, Italy
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Napoli, Italy
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Pordenone, Italy
Latvia
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Daugavpils, Latvia
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Riga, Latvia
Lithuania
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Vilnius, Lithuania
Norway
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Tronheim, Norway
Peru
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Lima, Peru
Poland
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Izabelin, Poland
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Lodz, Poland
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Lublin, Poland
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Mrozy, Poland
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Olsztyn, Poland
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Rzeszow, Poland
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Wejhrowo, Poland
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Wloclawek, Poland
Romania
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Bucharest, Romania
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Bucuresti, Romania
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Cluj-napoca, Romania
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Iasi, Romania
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Timisoara, Romania
South Africa
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Amanzimtoti, South Africa
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Bloemfontain, South Africa
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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George, South Africa
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Tygerberg, South Africa
Turkey
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Erzurum, Turkey
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Isparta, Turkey
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Istanbul, Turkey
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Kahramanmaras, Turkey
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Kayseri, Turkey
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Malatya, Turkey
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Manisa, Turkey
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Trabzon, Turkey
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Urfa, Turkey
United Kingdom
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Belfast, United Kingdom
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Chesterfield, United Kingdom
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Glasgow, United Kingdom
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Plymouth, United Kingdom
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Warminster, United Kingdom
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Watford, United Kingdom
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Whitstable, United Kingdom
Sponsors and Collaborators
Novartis
Schering-Plough
Investigators
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Study Chair: Novartis Pharma AG Novartis Pharmaceuticals

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00557466     History of Changes
Other Study ID Numbers: CQMF149B2201
First Posted: November 14, 2007    Key Record Dates
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: November 2012

Keywords provided by Novartis:
QMF
indacaterol
TWISTHALER® device

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents