Effect of Indacaterol on Inspiratory Capacity (IC)

NCT01012765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2016-02-17

Study results available
· View outcomes & findings →

Summary

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation

Conditions

Interventions

DRUG

Indacaterol

Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)

DRUG

Tiotropium

Tiotropium 18µg o.d. delivered via a proprietary inhalation device.

DRUG

Placebo

Placebo to indacaterol o.d. delivered via SDDPI

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012765 on ClinicalTrials.gov