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Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma

NCT02892019 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2020-01-27

Study results available
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Summary

This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.

Conditions

Interventions

DRUG

Indacaterol acetate 75 μg

Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler

DRUG

Indacaterol acetate 150 μg

Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2019-06-19
Completion
2019-07-17

Countries

  • Belgium
  • Colombia
  • Croatia
  • Germany
  • Guatemala
  • Hungary
  • Philippines
  • Russia
  • Slovakia
  • South Africa
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02892019 on ClinicalTrials.gov