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Does Asthma Phenotype Have Impact on Disease Control (Aperitif)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01978678
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment
Asthma Drug: Pulmicort

Detailed Description:
AHR used as outcome

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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Does Asthma Phenotype Have Impact on Disease Control - Can Detection of Inflammation and Hyper Responsiveness Ensure Stable Disease Faster
Study Start Date : November 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Group/Cohort Intervention/treatment
Pulmicort
ICS and LABA - based on ACQ and FeNO
Drug: Pulmicort
ACQ and FeNO
Other Name: RCT study




Primary Outcome Measures :
  1. Control of asthma based on an algorithm [ Time Frame: 2 years ]
    Based on ACQ and FeNO


Secondary Outcome Measures :
  1. The use of NO and sputum cell count as a marker in asthma management [ Time Frame: 2 years ]
    Based on ACQ and FeNO


Other Outcome Measures:
  1. the use of ACQ and miniAQLQ [ Time Frame: 2 years ]
    Based on ACQ and FeNO



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly referred asthma patients
Criteria

Inclusion Criteria:

  • positiv mannitol
  • asthma diagnose

Exclusion Criteria:

  • other lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978678


Locations
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Denmark
Department of Respiratory Medicine, L, Bispebjerg Hospital,
Copenhagen, NV, Denmark, 2400
Respiratory research unit, Bispebjerg University Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Vibeke Backer, MD Bispebjerg Hospital
Additional Information:

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Responsible Party: Vibeke Backer, DmSci, professor, md, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01978678    
Other Study ID Numbers: Aperitif
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: November 2013
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists