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Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

NCT00989833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-08-14

Study results available
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Summary

1. The primary objective of this study is:

* To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
2. The secondary objectives of this study are:

* To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
* To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event

Conditions

  • Exercise Induced Asthma

Interventions

DRUG

budesonide

400 yg x 1

DRUG

terbutaline

0.4 mg as-needed

DRUG

budesonide/formoterol

160/4.5 yg as-needed

Sponsors & Collaborators

Principal Investigators

  • Kjell Larsson, Professor · AstraZeneca MC Sweden

  • Georgios Stratelis · AstraZeneca MC Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Norway
  • Sweden

Study Locations

More Related Trials

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 NCT00989833 on ClinicalTrials.gov