UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042096 |
|---|---|
| Receipt number | R000048043 |
| Scientific Title | Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2021/01/12 10:17:20 |
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Basic information
Public title
Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis
Acronym
Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis
Scientific Title
Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic accuracy and adverse events of bronchial and intranasal challenge tests for NSAIDs-exacerbated respiratory disease: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
NSAIDs-exacerbated respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This systematic review aimed to evaluate the diagnostic accuracy and adverse events of inhalational challenge tests including bronchial and nasal challenge tests.
Basic objectives2
Others
Basic objectives -Others
Evaluating sensitivity and specificity as well as the number of adverse reactions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First, we will include the prospective or retrospective cohort studies, case-control studies, case series, and case reports describing aspirin inhalation challenge tests (bronchial or nasal challenge tests) for NERD in the review of adverse events.
Second, AS and HS will independently select the articles from include articles in adverse events review for systematic review and meta-analysis of diagnostic accuracy. Inclusion criteria for diagnostic test accuracy review will be prospective or retrospective cohort studies, and case-control studies assessing the accuracy of aspirin or ketorolac inhalational challenge tests for differentiating NERD and non-NERD patients. Exclusion criteria of diagnostic test accuracy review will be case series, case reports, review articles, and animal studies.
Key exclusion criteria
Mentioned above.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Shiroshita |
Organization
Ichinomiyanishi Hospital
Division name
Department of respiratory medicine
Zip code
491-0001
Address
1 Kaimeihira Chinomiya, Aichi, Japan, 494-0001
TEL
080-3807-4960
akihirokun8@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Shiroshita |
Organization
Ichinomiyanishi Hospital
Division name
Department of respiratory medicine
Zip code
491-0001
Address
1 Kaimeihira Chinomiya, Aichi, Japan, 494-0001
TEL
080-3807-4960
Homepage URL
akihirokun8@gmail.com
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
Funding Source
Organization
We obtained funding from Systematic Review Workshop Peer Support Group (SRWS-PSG) (https://community.camp-fire.jp/projects/view/187310).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For diagnostic test accuracy review, we will evaluate bronchial and intranasal aspirin challenge tests as a role of a replacement of oral aspirin challenge tests in specialized centers among patients who are suspected of NERD based on history and physical examination. We will extract the study information and evaluate the quality of the included studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.
Diagnostic accuracy of inhalation challenge tests will be evaluated with separate three categories; lysine-aspirin bronchial challenge tests, lysine-aspirin intranasal challenge tests, and ketorolac intranasal challenge tests. We will illustrate forest plots and hierarchical summary operating characteristic (HSROC) curves to summarize the diagnostic yield of inhalation challenge tests. Besides, we used a fixed specificity of 93% and calculate the point estimation of sensitivity using HSROC parameters. We used a fixed specificity of 93% because oral aspirin challenge tests had 93% of specificity for diagnosing NERD and we expect bronchial and intranasal challenge tests as similar add-on tests. The overall quality evidence will be assessed using the GRADE approach.
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048043
