NCT01978678

Brief Summary

The application of biomarkers that are more closely associated with eosinophillic airway inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial reactivity could improve asthma control by better directing treatment. A systematic review and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention on clinical symptoms compared with exhaled nitric oxide or induced sputum count.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 5, 2020

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

November 1, 2013

Last Update Submit

January 31, 2020

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Control of asthma based on an algorithm

    Based on ACQ and FeNO

    2 years

Secondary Outcomes (1)

  • The use of NO and sputum cell count as a marker in asthma management

    2 years

Other Outcomes (1)

  • the use of ACQ and miniAQLQ

    2 years

Study Arms (1)

Pulmicort

ICS and LABA - based on ACQ and FeNO

Drug: Pulmicort

Interventions

PulmicortDRUG

ACQ and FeNO

Also known as: RCT study
Pulmicort

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly referred asthma patients

You may qualify if:

  • positiv mannitol
  • asthma diagnose

You may not qualify if:

  • other lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Respiratory Medicine, L, Bispebjerg Hospital,

Copenhagen, NV, 2400, Denmark

Location

Respiratory research unit, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vibeke Backer, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DmSci, professor, md

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

November 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 5, 2020

Record last verified: 2013-11

Locations

DK(2)