NCT00989833

Brief Summary

  • 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 14, 2012

Completed
Last Updated

August 14, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

September 30, 2009

Results QC Date

August 22, 2011

Last Update Submit

July 6, 2012

Conditions

Exercise Induced Asthma

Keywords

Exercise induced asthmaMild intermittent asthmaExercise induced bronchoconstriction

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks

    FEV1

    Baseline and Visit 6

Secondary Outcomes (7)

  • Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks

    Baseline and 3 weeks

  • Bronchial Responsiveness to Mannitol

    Baseline and 6 weeks

  • Concentration of Exhaled Nitric Oxide

    6 weeks

  • Use of as Needed Medication

    6 weeks

  • Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)

    Baseline e and 6 weeks

  • +2 more secondary outcomes

Study Arms (3)

A

ACTIVE COMPARATOR

budesonide 400yg + terbutaline 0.4 mg as-needed

Drug: budesonideDrug: terbutaline

B

ACTIVE COMPARATOR

placebo + terbutaline 0.4 mg as-needed

Drug: terbutaline

C

ACTIVE COMPARATOR

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

Drug: budesonide/formoterol

Interventions

budesonideDRUG

400 yg x 1

Also known as: Pulmicort Turbuhaler
A
terbutalineDRUG

0.4 mg as-needed

Also known as: Bricanyl Turbuhaler
AB
budesonide/formoterolDRUG

160/4.5 yg as-needed

Also known as: Symbicort Turbuhaler
C

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Oslo, Norway

Location

Research Site

Trondheim, Norway

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Huddinge, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Skene, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24092567DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

BudesonideTerbutalineBudesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesFormoterol FumarateDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Kjell Larsson, Professor

    AstraZeneca MC Sweden

    PRINCIPAL INVESTIGATOR

  • Georgios Stratelis

    AstraZeneca MC Sweden

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 6, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 14, 2012

Results First Posted

August 14, 2012

Record last verified: 2012-07

Locations

SE(8)NO(2)