Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

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. Identifier: NCT00422552
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : June 22, 2007
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Brief Summary:
The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.

Condition or disease Intervention/treatment Phase
COPD Drug: Indacaterol (QAB149) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol
Study Start Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours

Secondary Outcome Measures :
  1. Percent predicted FEV1 time course change over 24 hours
  2. Mean maximal change in IC time course change over 24 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and post-menopausal female adults aged 40-80 years inclusive.
  • Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
  • Smoking history of at least 10 pack years (either smokers or ex-smokers).
  • Able to perform reproducible spirometry maneuvers.
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

  • COPD exacerbations within 6 weeks prior to dosing
  • Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
  • Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
  • Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

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 identifier (NCT number): NCT00422552

United Kingdom
Novartis Investigative site
Horsham, United Kingdom
Sponsors and Collaborators
Principal Investigator: Novartis Investigative site Identifier: NCT00422552     History of Changes
Other Study ID Numbers: CQAB149B2211
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007

Keywords provided by Novartis:
inspiratory capacity, FEV1, COPD

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Formoterol Fumarate
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