AsthmaGLAASNCT01618318
Glasgow Asthma and Allergy Study
An observational study of Asthma and Allergy, run by National Services for Health Improvement Ltd at 1 site in United Kingdom.
Trial summary
In the past, doctors separated people with asthma into two groups, those with "allergic asthma" (about 2/3rds of people) and those with "non-allergic asthma". These labels are not much used now as the treatments for all people with asthma don't depend on this classification. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Oct 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with asthma, non smoker, aged 18 and over.
Who may be able to join
- Male and female patients aged 18 years old and over with a diagnosis of asthma and having received at least two prescriptions for any asthma medication in the last 12 months, who have signed an informed consent form prior to initiation of any study-related procedure
Who cannot join
- under 18 years
- current smokers
- unwilling or unable to give informed consent
- a clinical diagnosis of COPD
- a history of anaphylaxis (skin prick test)
- participated in any clinical study in the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Sectional Study to Evaluate and Associate Clinical and Laboratory Features of People With Allergic and Non-allergic Asthma
In the past, doctors separated people with asthma into two groups, those with "allergic asthma" (about 2/3rds of people) and those with "non-allergic asthma". These labels are not much used now as the treatments for all people with asthma don't depend on this classification. However, new treatments for asthma may become available and the classification may again become important. It could be useful for clinicians to know how to identify which patients are likely to benefit from particular treatments.
Additionally, some new blood tests are becoming available and some of these might help to categorise the type of asthma people have. What the study hopes to do is to identify patient features which make a diagnosis of "allergic asthma" more likely and to see which new blood tests are most likely to be helpful in confirming this diagnosis.
- Keywords
- Asthma, Allergy, Diagnosis, Correlation study
- Medical subject headings
- Asthma, Hypersensitivity, Disease
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 |
|---|---|---|
| General asthma population | People with asthma, aged 18 years and over, non smoker, all severities of disease, regardless of treatment, broad inclusion and few exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum periostin level
This is a cross sectional study. Participants will be assessed and tests conducted at a single visit
Measured: 1 day
Secondary outcomes (7)
skin prick test
Measured: 1 day
Serum total IgE
Measured: 1 day
Blood eosinophil count
Measured: 1 day
Blood neutrophil count
Measured: 1 day
Blood CD4 cells that are positive for CRTh2
Measured: 1 day
Blood eosinophils expressing CRTh2
Measured: 1 day
Spirometry
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 posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Services for Health Improvement Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- John A Haughney, MB ChB, Principal investigator, NSHI Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618318
- Sponsor's protocol ID
- 12/WS/0049
- Acronym
- GLAAS
- Status last verified
- Dec 2013
- First submitted
- 8 Jun 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study to Evaluate and Associate Clinical and Laboratory Features of People With Allergic and Non-allergic Asthma
- ClinicalTrials.gov ID
- NCT01618318
- Acronym / sponsor ID
- GLAAS / 12/WS/0049
- Keywords
- Asthma, Allergy, Diagnosis, Correlation study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Services for Health Improvement LtdIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jun 2012 (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.
In the past, doctors separated people with asthma into two groups, those with "allergic asthma" (about 2/3rds of people) and those with "non-allergic asthma". These labels are not much used now as the treatments for all people with asthma don't depend on this classification. However, new treatments for asthma may become available and the classification may again become important. It could be useful for clinicians to know how to identify which patients are likely to benefit from particular treatments.
Additionally, some new blood tests are becoming available and some of these might help to categorise the type of asthma people have. What the study hopes to do is to identify patient features which make a diagnosis of "allergic asthma" more likely and to see which new blood tests are most likely to be helpful in confirming this diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General asthma population | – | –People with asthma, aged 18 years and over, non smoker, all severities of disease, regardless of treatment, broad inclusion and few exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with asthma, non smoker, aged 18 and over.
Key inclusion criteria (1 listed)
- Male and female patients aged 18 years old and over with a diagnosis of asthma and having received at least two prescriptions for any asthma medication in the last 12 months, who have signed an informed consent form prior to initiation of any study-related procedure
Key exclusion criteria (6 listed)
- under 18 years
- current smokers
- unwilling or unable to give informed consent
- a clinical diagnosis of COPD
- a history of anaphylaxis (skin prick test)
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
Serum periostin level
Time frame: 1 day
This is a cross sectional study. Participants will be assessed and tests conducted at a single visit
7 secondary outcomes
skin prick test
Time frame: 1 day
Serum total IgE
Time frame: 1 day
Blood eosinophil count
Time frame: 1 day
Blood neutrophil count
Time frame: 1 day
Blood CD4 cells that are positive for CRTh2
Time frame: 1 day
Blood eosinophils expressing CRTh2
Time frame: 1 day
Spirometry
Time frame: 1 day
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 Dec 2013.
Related trials for Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
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.
John A Haughney, MB ChB principal investigator
NSHI Ltd
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 and Allergy, run by National Services for Health Improvement Ltd at 1 site in United Kingdom.
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 1 inclusion and 6 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 Dec 2013. 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 United Kingdom. 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?
Serum periostin level (time frame: 1 day). 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 Dec 2013.