UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010030 |
|---|---|
| Receipt number | R000011746 |
| Scientific Title | Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the efficacy of 3 times nebulized Amphotericin B on cough symptoms in chronic cough patients with Bjerkandera adusta cultured |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2013/08/13 13:37:07 |
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Basic information
Public title
Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the efficacy of 3 times nebulized Amphotericin B on cough symptoms in chronic cough patients with Bjerkandera adusta cultured
Acronym
Efficacy of multiple nebulized Amphotericin B on chronic cough cough with Bjerkandera adusta cultured
Scientific Title
Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the efficacy of 3 times nebulized Amphotericin B on cough symptoms in chronic cough patients with Bjerkandera adusta cultured
Scientific Title:Acronym
Efficacy of multiple nebulized Amphotericin B on chronic cough cough with Bjerkandera adusta cultured
Region
| Japan |
Condition
Condition
Chronic cough with basidiomycetous fungi cultured from their sputum or pharyngeal swab
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic advantage of Nebulizer inhalation of Amphotericin B or combination of Amphotericin B and corticosteroids in treating chronic cough with B. adusta cultured is compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in cough symptoms using Japanese version of LCQ scores, Cough-related laryngeal sensation questionnaire, value of FENO, capsaicin cough thresholds are evaluated.
Key secondary outcomes
The successful eradication of B.adusta cultured is estimated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nebulizer inhalation of 2.5 mg Amphotericin B for three times(day 1,3,5)
Interventions/Control_2
Nebulizer inhalation of combination of 1.25 mg Amphotericin B and 0.25 mg Budesonide for three times(day 1,3,5)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with bronchodilator(a combination of oral clenbuterol and salbutamol inhalation at bedtime or when required) resistive cough lasting eight weeks or more with Bjerkandera adusta cultured.
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
Target sample size
10
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
Public contact
Name of contact person
| 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
076-266-1060
Homepage URL
saiseikh@po3.nsknet.or.jp
Sponsor or person
Institute
Ishikawa-ken Saiseikai Kanazawa Hospital.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Respiratory Medicine, Cellular Transplantation Biology, Kanazawa University Graduate School of Medicine.
Respiratory Medicine, National Hospital Organization Nanao Hospital.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 02 | Month | 20 | 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
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 13 | Day |
Last modified on
| 2013 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011746
