NCT00422552

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
Last Updated

June 22, 2007

Status Verified

June 1, 2007

First QC Date

January 16, 2007

Last Update Submit

June 21, 2007

Conditions

COPD

Keywords

inspiratory capacity, FEV1, COPD

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Percent predicted FEV1 time course change over 24 hours

  • Mean maximal change in IC time course change over 24 hours

Interventions

Indacaterol (QAB149)DRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative site

Horsham, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    Investigative site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Study Start

September 1, 2006

Last Updated

June 22, 2007

Record last verified: 2007-06

Locations

GB(1)