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Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00396604
Recruitment Status : Completed
First Posted : November 7, 2006
Last Update Posted : October 25, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive Drug: indacaterol maleate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.
Study Start Date : October 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

Secondary Outcome Measures :
  1. FEV1 at time points 30 min, 1, 2 and 4hours post-dose
  2. Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
  3. Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
  4. Standardized FEV1 area under the curve (AUC) between baseline and 4 hours


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
  • Smoking history of at least 10 pack years
  • FEV1 less than 65% of the predicted normal value and at least 0.75 L
  • Pre-bronchodilator FEV1/FVC less than 70%

Exclusion Criteria:

  • A history of asthma or COPD diagnosis before the age of 40
  • Hospitalization for COPD exacerbation within the previous 6 weeks
  • Respiratory tract infection within 6 weeks
  • Use of long-term oxygen therapy
  • Diabetes type I or uncontrolled diabetes type II
  • Clinically relevant laboratory abnormality or clinically significant condition
  • Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. 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): NCT00396604


Locations
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Belgium
Novartis
Vilvoorde, Belgium
Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Novartis Novartis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00396604    
Other Study ID Numbers: CQAB149B2212
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Keywords provided by Novartis:
indacaterol
long acting beta agonist
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action