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Symbicort Rapihaler Therapeutic Equivalence Study

NCT00536731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 742

Last updated 2012-08-15

Study results available
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Summary

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Symbicort Turbuhaler

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

DRUG

Symbicort pMDI

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

DRUG

Pulmicort Turbuhaler

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Sponsors & Collaborators

Principal Investigators

  • Tomas Andersson · AstraZeneca

  • Akos Somoskovi · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Poland

Study Locations

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Entities

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 NCT00536731 on ClinicalTrials.gov