AsthmaAperitifNCT01978678
Does Asthma Phenotype Have Impact on Disease Control
An observational study of Asthma, run by Bispebjerg Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pulmicort
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2012to Jan 2015
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly referred asthma patients
Who may be able to join
- positiv mannitol
- asthma diagnose
Who cannot join
- other lung disease
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Respiratory Medicine, L, Bispebjerg Hospital,
Copenhagen, NV, 2400
Respiratory research unit, Bispebjerg University Hospital
Copenhagen, 2400
About this study
Official title: 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.
Read the detailed description
AHR used as outcome
- Conditions
- Asthma
- Being tested
- Pulmicort
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulmicortDrug
Also called RCT study
ACQ and FeNO
| Study group | Role | What they receive |
|---|---|---|
| Pulmicort | ICS and LABA - based on ACQ and FeNO Receives: Drug: Pulmicort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of asthma based on an algorithm
Based on ACQ and FeNO
Measured: 2 years
Secondary outcomes (1)
The use of NO and sputum cell count as a marker in asthma management
Based on ACQ and FeNO
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978678
- Sponsor's protocol ID
- Aperitif
- Acronym
- Aperitif
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2013
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Asthma Phenotype Have Impact on Disease Control - Can Detection of Inflammation and Hyper Responsiveness Ensure Stable Disease Faster
- ClinicalTrials.gov ID
- NCT01978678
- Acronym / sponsor ID
- Aperitif / Aperitif
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AHR used as outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmicort | – | Drug: PulmicortICS and LABA - based on ACQ and FeNO |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly referred asthma patients
Key inclusion criteria (2 listed)
- positiv mannitol
- asthma diagnose
Key exclusion criteria (1 listed)
- other lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulmicortAlso: RCT studyACQ and FeNO | Drug | Pulmicort |
Primary outcome
Control of asthma based on an algorithm
Time frame: 2 years
Based on ACQ and FeNO
1 secondary outcome
The use of NO and sputum cell count as a marker in asthma management
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Backer, MD principal investigator
Bispebjerg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Bispebjerg Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of asthma based on an algorithm (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.