UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Acronym	Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Scientific Title	Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Scientific Title:Acronym	Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Region	Japan

Condition
Condition	bird fancier's lung
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This systematic review aimed to assess the diagnostic accuracy of inhalation challenge tests and adverse reactions after the tests.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity and specificity of inhalation challenge tests
Key secondary outcomes	Complication after inhalation challenge tests

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	1.Randomized control trials, prospective or retrospective cohort studies, or case-control studies assessing either the sensitivity and specificity of inhalation challenge tests among patients who were suspected of BFL, 2. Randomized control trials, prospective or retrospective cohort studies, case-control studies, case series, or case reports describing adverse reactions of inhalation challenge tests.
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Shiroshita
Organization	Kameda Medical Center
Division name	Department of pulmonology
Zip code	2968602
Address	929, Higashi-cho, Kamogawa city, Chiba
TEL	0470922211
Email	akihirokun8@gmail.com

Public contact
Name of contact person	1st name Akihiro Middle name Shiroshita Last name Shiroshita
Organization	Kameda Medical Center
Division name	Department of pulmonology
Zip code	2968602
Address	929, Higashi-cho, Kamogawa city, Chiba
TEL	0470922211
Homepage URL
Email	akihirokun8@gmail.com

Sponsor
Institute	Kameda Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kameda Medical Center
Address	929, Higashi-cho, Kamogawa city, Chiba
Tel	0470922211
Email	akihirokun8@gmail.com

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	2019 Year 12 Month 05 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	Completed
Date of protocol fixation	2019 Year 12 Month 05 Day
Date of IRB	2019 Year 12 Month 05 Day
Anticipated trial start date	2019 Year 12 Month 05 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We searched for articles evaluating diagnostic accuracy of inhalation challenge tests or articles describing adverse reaction, in Medline, Embase, the Cochrane Library, the International Clinical Trials Registry Platform, and the Web of Science. We described a hierarchical summary receiver operating characteristic (HSROC) curve to evaluate sensitivity and specificity of the challenge tests. We summarized subjective adverse reactions and use of steroid treatment for adverse reactions described in the articles.

Management information
Registered date	2019 Year 12 Month 05 Day
Last modified on	2020 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044234