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

NCT ID: NCT00989833

Last Updated: 2012-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Exercise Induced Asthma

Keywords

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Exercise induced asthma Mild intermittent asthma Exercise induced bronchoconstriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

budesonide 400yg + terbutaline 0.4 mg as-needed

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

400 yg x 1

terbutaline

Intervention Type DRUG

0.4 mg as-needed

B

placebo + terbutaline 0.4 mg as-needed

Group Type ACTIVE_COMPARATOR

terbutaline

Intervention Type DRUG

0.4 mg as-needed

C

placebo + budesonide/formoterol 160/4.5 yg as-needed

Group Type ACTIVE_COMPARATOR

budesonide/formoterol

Intervention Type DRUG

160/4.5 yg as-needed

Interventions

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budesonide

400 yg x 1

Intervention Type DRUG

terbutaline

0.4 mg as-needed

Intervention Type DRUG

budesonide/formoterol

160/4.5 yg as-needed

Intervention Type DRUG

Other Intervention Names

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Pulmicort Turbuhaler Bricanyl Turbuhaler Symbicort Turbuhaler

Eligibility Criteria

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Inclusion Criteria

* History of exercise induced asthma
* Maximum 4 asthmatic episodes per week requiring use of reliever medication

Exclusion Criteria

* No previous treatment with inhaled oral corticosteroids during the last month before randomisation
* Suspected poor capability to follow instructions, ie to exercise 3-4 times a week
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjell Larsson, Professor

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca MC Sweden

Georgios Stratelis

Role: STUDY_DIRECTOR

AstraZeneca MC Sweden

Locations

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Research Site

Oslo, , Norway

Site Status

Research Site

Trondheim, , Norway

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Huddinge, , Sweden

Site Status

Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Research Site

Skene, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Norway Sweden

References

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Lazarinis N, Jorgensen L, Ekstrom T, Bjermer L, Dahlen B, Pullerits T, Hedlin G, Carlsen KH, Larsson K. Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction. Thorax. 2014 Feb;69(2):130-6. doi: 10.1136/thoraxjnl-2013-203557. Epub 2013 Oct 3.

Reference Type DERIVED
PMID: 24092567 (View on PubMed)

Other Identifiers

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D5890L00032

Identifier Type: -

Identifier Source: org_study_id