NCT01618318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

June 8, 2012

Last Update Submit

December 4, 2013

Conditions

Keywords

AsthmaAllergyDiagnosisCorrelation study

Outcome Measures

Primary Outcomes (1)

  • Serum periostin level

    This is a cross sectional study. Participants will be assessed and tests conducted at a single visit

    1 day

Secondary Outcomes (7)

  • skin prick test

    1 day

  • Serum total IgE

    1 day

  • Blood eosinophil count

    1 day

  • Blood neutrophil count

    1 day

  • Blood CD4 cells that are positive for CRTh2

    1 day

  • +2 more secondary outcomes

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NSHI Ltd

Dartford, Kent, DA1 5GA, United Kingdom

Location

MeSH Terms

Conditions

AsthmaHypersensitivityDisease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John A Haughney, MB ChB

    NSHI Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 13, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations