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

June 21, 2007 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours

Secondary Outcome Measures

Outcome Measure
Percent predicted FEV1 time course change over 24 hours
Mean maximal change in IC time course change over 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

June 22, 2007

Last Update Submitted That Met QC Criteria

June 21, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149B2211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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