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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01618318
Other study ID # 12/WS/0049
Secondary ID
Status Completed
Phase N/A
First received June 8, 2012
Last updated December 4, 2013
Start date June 2012
Est. completion date October 2013

Study information

Verified date December 2013
Source National Services for Health Improvement Ltd
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom NSHI Ltd Dartford Kent

Sponsors (2)

Lead Sponsor Collaborator
National Services for Health Improvement Ltd Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum periostin level This is a cross sectional study. Participants will be assessed and tests conducted at a single visit 1 day No
Secondary skin prick test 1 day No
Secondary Serum total IgE 1 day No
Secondary Blood eosinophil count 1 day No
Secondary Blood neutrophil count 1 day No
Secondary Blood CD4 cells that are positive for CRTh2 1 day No
Secondary Blood eosinophils expressing CRTh2 1 day No
Secondary Spirometry 1 day No
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