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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004933
Receipt No. R000005872
Scientific Title EXPERIENCES WITH CHRONIC IDIOPATIC COUGH PATIENTS TREATED WITH LOW-DOSE ITRACONAZOLE
Date of disclosure of the study information 2011/01/29
Last modified on 2012/01/23

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Basic information
Public title EXPERIENCES WITH CHRONIC IDIOPATIC COUGH PATIENTS TREATED WITH LOW-DOSE ITRACONAZOLE

Acronym EXPERIENCES WITH CHRONIC IDIOPATIC COUGH PATIENTS TREATED WITH LOW-DOSE ITRACONAZOLE

Scientific Title EXPERIENCES WITH CHRONIC IDIOPATIC COUGH PATIENTS TREATED WITH LOW-DOSE ITRACONAZOLE

Scientific Title:Acronym EXPERIENCES WITH CHRONIC IDIOPATIC COUGH PATIENTS TREATED WITH LOW-DOSE ITRACONAZOLE

Region
Japan

Condition
Condition Chronic idiopathic cough
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to examine the efficacy of itraconazole (ITZ) in CIC patients and to try to clarify the allergological pattern to predict the outcome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical response to each treatment was monitored by changes in cough sensitivity and the Leicester Cough Questionnaire (LCQ) measured during the 2-week periods at the end of each phase.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral prednisolone (10 mg/day)
a low dose of ITZ (50 mg/day)
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
18 years-old <
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria CIC patients who are suffering from cough symptoms more than 2years.
Key exclusion criteria 1) Patients having abnormal shadow on chest X-ray
2) Patients having wheezing audible
3) Patients having obstructive disorders in pulmonary function testing
4) Patients having severe complications
5) Patients having pulmonary tuberclosis
6) Jpatients without agreement
7) Patients being pregnant, possible pregnant or breast-feeding a baby
8) Patients judged inappropriate by attending physisians
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Ogawa
Organization Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name The Division of Pulmonary Medicine
Zip code
Address Akatsuchi-machi ni 13-6, Kanazawa, Japan 920-0953
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name The Division of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
Email foresth@mail.goo.ne.jp

Sponsor
Institute Ishikawa-ken Saiseikai Kanazawa Hospital.
Institute
Department

Funding Source
Organization Ishikawa-ken Saiseikai Kanazawa Hospital.
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
Address
Tel
Email

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
2011 Year 01 Month 29 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
We selected 8 patients with CIC and carried out allergological examinations for Bjerkandera adusta (B. adusta), a BM fungus that has been shown to enhance cough severity. As adjunctive therapies, the patients were treated with oral prednisolone (10 mg/day) for 14 days after a 2-week observation period, and subsequently they received a low dose of ITCZ (50 mg/day) for 14 days. Clinical response to each treatment was monitored by the Japanese version of the Leicester Cough Questionnaire. We evaluated whether there was a recognizable clinical pattern that could distinguish ITCZ-responsive CIC (R-CIC) from ITCZ-non-responsive CIC (NR-CIC). (Results) Positive results for an immediate cutaneous reaction to B. adusta were observed in 4 patients in the R-CIC group (100%) and in 1 patient in the NR-CIC group (25.0%). The positive ratio for the skin test was significantly different between the groups (P<0.05). (Conclusions) Efficacy of ITCZ was demonstrated in a cluster of CIC patients. A positive result of immediate cutaneous reaction to B. adusta may aid in the successful management of CIC.
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
2010 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 23 Day
Last modified on
2012 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005872

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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