- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978678
Does Asthma Phenotype Have Impact on Disease Control (Aperitif)
January 31, 2020 updated by: Vibeke Backer, Bispebjerg Hospital
Does Asthma Phenotype Have Impact on Disease Control - Can Detection of Inflammation and Hyper Responsiveness Ensure Stable Disease Faster
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.
Study Overview
Detailed Description
AHR used as outcome
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2400
- Respiratory research unit, Bispebjerg University Hospital
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NV
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Copenhagen, NV, Denmark, 2400
- Department of Respiratory Medicine, L, Bispebjerg Hospital,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Newly referred asthma patients
Description
Inclusion Criteria:
- positiv mannitol
- asthma diagnose
Exclusion Criteria:
- other lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pulmicort
ICS and LABA - based on ACQ and FeNO
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ACQ and FeNO
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Control of asthma based on an algorithm
Time Frame: 2 years
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Based on ACQ and FeNO
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The use of NO and sputum cell count as a marker in asthma management
Time Frame: 2 years
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Based on ACQ and FeNO
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2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the use of ACQ and miniAQLQ
Time Frame: 2 years
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Based on ACQ and FeNO
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vibeke Backer, MD, Bispebjerg Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 1, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 7, 2013
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 31, 2020
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- Aperitif
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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