Glasgow Asthma and Allergy Study (GLAAS)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
National Services for Health Improvement Ltd
ClinicalTrials.gov Identifier:
NCT01618318
First received: June 8, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition
Asthma
Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross Sectional Study to Evaluate and Associate Clinical and Laboratory Features of People With Allergic and Non-allergic Asthma

Resource links provided by NLM:


Further study details as provided by National Services for Health Improvement Ltd:

Primary Outcome Measures:
  • Serum periostin level [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    This is a cross sectional study. Participants will be assessed and tests conducted at a single visit


Secondary Outcome Measures:
  • skin prick test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Serum total IgE [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood eosinophil count [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood neutrophil count [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood CD4 cells that are positive for CRTh2 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood eosinophils expressing CRTh2 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Spirometry [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with asthma, non smoker, aged 18 and over.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618318

Locations
United Kingdom
NSHI Ltd
Dartford, Kent, United Kingdom, DA1 5GA
Sponsors and Collaborators
National Services for Health Improvement Ltd
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: John A Haughney, MB ChB NSHI Ltd
  More Information

No publications provided

Responsible Party: National Services for Health Improvement Ltd
ClinicalTrials.gov Identifier: NCT01618318     History of Changes
Other Study ID Numbers: 12/WS/0049
Study First Received: June 8, 2012
Last Updated: December 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by National Services for Health Improvement Ltd:
Asthma
Allergy
Diagnosis
Correlation study

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 20, 2014