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Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

NCT01012739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-08-29

Study results available
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Summary

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

Conditions

Interventions

DRUG

Indacaterol 150 μg via the Concept1 dry-powder inhaler

Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.

DRUG

Indacaterol 60 μg via the Simoon dry-powder inhaler

Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

DRUG

Indacaterol 120 μg via the Simoon dry-powder inhaler

Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

DRUG

Placebo to indacaterol via the Concept1 dry-powder inhaler

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT01012739 on ClinicalTrials.gov