UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009007 |
|---|---|
| Receipt number | R000010569 |
| Scientific Title | Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the acute effect of single nebulized Amphotericin B on cough symptoms in bronchodilator resistive cough patients |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2013/03/30 22:34:22 |
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Basic information
Public title
Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the acute effect of single nebulized Amphotericin B on cough symptoms in bronchodilator resistive cough patients
Acronym
Effect of single nebulized Amphotericin B on cough in bronchodilator resistive cough
Scientific Title
Randomized, single-blinded, placebo-controlled, parallel-group trial to clarify the acute effect of single nebulized Amphotericin B on cough symptoms in bronchodilator resistive cough patients
Scientific Title:Acronym
Effect of single nebulized Amphotericin B on cough in bronchodilator resistive cough
Region
| Japan |
Condition
Condition
Bronchodilator resistive chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The therapeutic advantage of Nebulizer inhalation Amphotericin B against Budesonide in treating chronic cough.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate cough symptoms using CHQ scores
Key secondary outcomes
To compare the pattern of change in CHQ and FENO after treatment between FACC and non FACC patients
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 100 mg Amphotericin B
Interventions/Control_2
Nebulizer inhalation of 0.5 mg Budesonide
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 resistive chough lasting eight weeks or more
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
28
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
076-266-1060
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Ueda |
Organization
Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name
Pharmacy
Zip code
Address
TEL
Homepage URL
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)
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
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 29 | Day |
Last modified on
| 2013 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010569
