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Efficacy and Safety of Different Doses of Indacaterol

NCT01079130 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2011-08-19

Study results available
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Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Conditions

Interventions

DRUG

Indacaterol

Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.

DRUG

Salmeterol

50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

DRUG

Placebo to Indacaterol

Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.

DRUG

Placebo to Salmeterol

Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31

Countries

  • United States

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 NCT01079130 on ClinicalTrials.gov