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Challenge Test for Acetylsalicylic Acid Hypersensitivity

Primary Purpose

Asthma Aspirin-sensitive, ASA Intolerant Asthma, Asthma, Aspirin-Induced

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Acetylsalicylate
Isotonic NaCl
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma Aspirin-sensitive focused on measuring Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic Hypersensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Persons between 18 and 60 years of age
  • Suspected Acetylsalicylic Acid Hypersensitivity

Exclusion Criteria:

  • History on anaphylactic shock after NSAIDS intake
  • History on gastric ulcer after NSAIDS intake
  • Patients previously gone through testing or desensitisation for Aspirin hypersensitivity
  • Clinical unstable asthma or baseline FEV1<70%
  • Severe disease of the heart, digestive tract, liver or kidney
  • Severe chronic urticaria
  • Present conjunctivitis
  • Pregnancy

Sites / Locations

  • Akershus University Hospital
  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetylsalicylate

isotonic NaCl

Arm Description

Acetylsalicylic Acid Eyedrops

Saline Eyedrops

Outcomes

Primary Outcome Measures

Inspiratory nasal flow measured by Rhinomanometry
Bilateral flow reduction >40% considered positive test.
Expiratory nasal flow measured by Rhinomanometry
Bilateral expiratory flow reduction >40% considered positive.
Pulmonary forced expiratory volume in 1 second (FEV1)
Reduction in FEV1 >20% is considered as positive test.

Secondary Outcome Measures

Conjunctival symptoms
0=no symptoms, 1=limited redness and / or itching, 2=conjunctival redness and /or itching / swelling or bullae within 5 minutes from testing. Value 1 and 2 is considered positive if unilateral.
Nasal symptoms
Rhinorrhea, congestion and sneezing is considered as positive test.
Bronchial and laryngeal symptoms
Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.

Full Information

First Posted
August 9, 2012
Last Updated
September 12, 2012
Sponsor
Helse Stavanger HF
Collaborators
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT01681615
Brief Title
Challenge Test for Acetylsalicylic Acid Hypersensitivity
Official Title
Challenge Test for Acetylsalicylic Acid Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
University Hospital, Akershus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.
Detailed Description
Hypersensitivity to Acetylsalicylic Acid or Aspirin (and other NSAIDS) is a condition that affects up to 2,5% of the population. Most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. Despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. So far oral, nasal, inhalation and intravenous routes of administration has been described in literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Aspirin-sensitive, ASA Intolerant Asthma, Asthma, Aspirin-Induced, Asthma, Nasal Polyps, and Aspirin Intolerance
Keywords
Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic Hypersensitivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetylsalicylate
Arm Type
Active Comparator
Arm Description
Acetylsalicylic Acid Eyedrops
Arm Title
isotonic NaCl
Arm Type
Placebo Comparator
Arm Description
Saline Eyedrops
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylate
Intervention Description
1-2 drops
Intervention Type
Drug
Intervention Name(s)
Isotonic NaCl
Intervention Description
1 drop
Primary Outcome Measure Information:
Title
Inspiratory nasal flow measured by Rhinomanometry
Description
Bilateral flow reduction >40% considered positive test.
Time Frame
Within 45 min from challenge
Title
Expiratory nasal flow measured by Rhinomanometry
Description
Bilateral expiratory flow reduction >40% considered positive.
Time Frame
Within 45 min from challenge
Title
Pulmonary forced expiratory volume in 1 second (FEV1)
Description
Reduction in FEV1 >20% is considered as positive test.
Time Frame
Within 45 min from challenge
Secondary Outcome Measure Information:
Title
Conjunctival symptoms
Description
0=no symptoms, 1=limited redness and / or itching, 2=conjunctival redness and /or itching / swelling or bullae within 5 minutes from testing. Value 1 and 2 is considered positive if unilateral.
Time Frame
Within 45 days from challenge
Title
Nasal symptoms
Description
Rhinorrhea, congestion and sneezing is considered as positive test.
Time Frame
Within 45 minutes from challenge
Title
Bronchial and laryngeal symptoms
Description
Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
Time Frame
Within 45 minutes from challenge
Other Pre-specified Outcome Measures:
Title
Other significant and relevant symptoms
Description
Erythema in upper body or face, nausea or abdominal pain is considered as positive test.
Time Frame
Within 45 days after challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persons between 18 and 60 years of age Suspected Acetylsalicylic Acid Hypersensitivity Exclusion Criteria: History on anaphylactic shock after NSAIDS intake History on gastric ulcer after NSAIDS intake Patients previously gone through testing or desensitisation for Aspirin hypersensitivity Clinical unstable asthma or baseline FEV1<70% Severe disease of the heart, digestive tract, liver or kidney Severe chronic urticaria Present conjunctivitis Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Bachmann-Harlidstad, MD, PhD
Phone
0047 02900 (central)
Email
Gregor.Bachmann-Harlidstad2@ahus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jörg Törpel, MD
Phone
0047 05151 (central)
Email
jörg.törpel@sus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Bachmann-Harildstad, MD, PhD
Organizational Affiliation
University in Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor Bachmann-Harlidstad, MD, PhD
Phone
0047 02900 (central)
Email
gregor.bachmann.harlidstad2@ahus.no
First Name & Middle Initial & Last Name & Degree
Mohammad Sohrabi, MD
Phone
0047 02900 (central)
Email
mohammad.sohrabi@ahus.no
First Name & Middle Initial & Last Name & Degree
Gregor Bachmann-Harildstad, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mohammad Sohrabi, MD
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4068
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Torp, MD
Phone
0047 05151 (central)
Email
anders.torp@sus.no
First Name & Middle Initial & Last Name & Degree
Jörg Törpel, MD
Phone
0047 05151 (central)
Email
jörg.törpel@sus.no
First Name & Middle Initial & Last Name & Degree
Anders Torp, MD
First Name & Middle Initial & Last Name & Degree
Jörg Törpel, MD

12. IPD Sharing Statement

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Challenge Test for Acetylsalicylic Acid Hypersensitivity

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