AsthmaNCT01350661
Correlation Between Five Asthma Control Questionnaires
An observational study of Asthma, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Jun 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen at the consultation of pulmonology of a tertiary hospital.
Who may be able to join
- Diagnosis of asthma confirmed by a pulmonologist
- Patient have had a lung function testing on the same day than the questionnaires are fulfilled.
- Age equal or upper than 18 years
- Agreement to participate to this study
Who cannot join
- Age under 18 years
- Refusal to participate to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Correlation Between Five Asthma Control Questionnaires
This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.
The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).
- Conditions
- Asthma
- Keywords
- Asthma, Questionnaires
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma control level assessment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of asthma control
The five questionnaires are completed succesively on the same time.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Inge Muylle, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350661
- Sponsor's protocol ID
- B07620109010
- Status last verified
- Aug 2015
- First submitted
- 9 May 2011
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vermeulen F, de Meulder I, Paesmans M, Muylle I, Bruyneel M, Ninane V. Asthma control measurement using five different questionnaires: a prospective study. Respir Med. 2013 Sep;107(9):1314-21. doi: 10.1016/j.rmed.2013.07.003. Epub 2013 Jul 26.
PubMed 23890766
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Correlation Between Five Asthma Control Questionnaires
- ClinicalTrials.gov ID
- NCT01350661
- Acronym / sponsor ID
- B07620109010
- Conditions
- Asthma
- Keywords
- Asthma, Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 May 2011 (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.
This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.
The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma control level assessment | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen at the consultation of pulmonology of a tertiary hospital.
Key inclusion criteria (4 listed)
- Diagnosis of asthma confirmed by a pulmonologist
- Patient have had a lung function testing on the same day than the questionnaires are fulfilled.
- Age equal or upper than 18 years
- Agreement to participate to this study
Key exclusion criteria (2 listed)
- Age under 18 years
- Refusal to participate to this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of asthma control
Time frame: 1 day
The five questionnaires are completed succesively on the same time.
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 10 Aug 2015.
- Derived from this study: PubMed 23890766Vermeulen F, de Meulder I, Paesmans M, Muylle I, Bruyneel M, Ninane V. Asthma control measurement using five different questionnaires: a prospective study. Respir Med. 2013 Sep;107(9):1314-21. doi: 10.1016/j.rmed.2013.07.003. Epub 2013 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 4 inclusion and 2 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 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Level of asthma control (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350661, which also lists 1 linked publication.
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 10 Aug 2015.