UMIN-CTR Clinical Trial

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

Chronic idiopathic cough

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Ishikawa-ken Saiseikai Kanazawa Hospital.

Institute

Department

Personal name

Organization

Ishikawa-ken Saiseikai Kanazawa Hospital.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

01

Month

23

Day

Last modified on

2012

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005872