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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00422552
First received: January 16, 2007
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
COPD
Drug: Indacaterol (QAB149)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Estimated Enrollment: 30
Study Start Date: September 2006
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422552

Locations
United Kingdom
Novartis Investigative site
Horsham, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422552     History of Changes
Other Study ID Numbers: CQAB149B2211
Study First Received: January 16, 2007
Last Updated: June 21, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
inspiratory capacity, FEV1, COPD

Additional relevant MeSH terms:
Respiratory Aspiration
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases, Obstructive
Lung Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014