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OpenTrials
Completed

NCT Number: NCT00422552

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative site

Horsham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol (QAB149)

Drug

Primary outcomes

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

Secondary outcomes

  1. Percent predicted FEV1 time course change over 24 hours

  2. Mean maximal change in IC time course change over 24 hours

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Jan 17, 2007
Registry last updated
Jun 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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