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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010030
Receipt No. 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

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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
Email

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
Email saiseikh@po3.nsknet.or.jp

Sponsor
Institute Ishikawa-ken Saiseikai Kanazawa Hospital.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011746

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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