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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002665
Receipt No. R000003245
Scientific Title Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Date of disclosure of the study information 2009/10/25
Last modified on 2018/01/10

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Basic information
Public title Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Acronym Comparison of ciclesonide and fluticasone on small airway in asthmatics
Scientific Title Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Scientific Title:Acronym Comparison of ciclesonide and fluticasone on small airway in asthmatics
Region
Japan

Condition
Condition asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy and safety of high-dose and same-dose fluticasone propionate-dry powder inhalar and ciclesonide-hydrofluoroalkane on small airway funtion and inflammation in asthmatics.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of lung function and respiratory resistance
Key secondary outcomes Improvement of small airway inflammation and the frequency of adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A) ciclesonide (800mcg/, 14days)-28days washout-fluticasone (800mcg/, 14days)
Interventions/Control_2 B) fluticasone (800mcg/, 14days)-28days washout-ciclesonide (800mcg/, 14days)
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Asthma is diagnosed in based on GINA 2006.
2. PC20 to methacholine < 16mg/mL.
3. non-smoker
4. stable status (>4wks)
Key exclusion criteria 1. Inhaled, oral and injective corticosteroids, leukotriene receptor antagonists, inhaled, oral and transdermal long acting beta2 agonists,sodiumchromoglicate, xanthine, immunosuppressive agents, and anti-allergic agents (include anti-IgE antibody) is used 4wks prior to screening.
2. Respiratory infections (within 4wks)
3. Other underlying diseases
4. Any psychological disease
5. Pregnacy
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisamichi Aizawa
Organization Kurume University School of Medicine
Division name Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan
TEL 0942-31-7560
Email kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomotaka Kawayama
Organization Kurume University School of Medicine
Division name Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan
TEL 0942-31-7560
Homepage URL
Email kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Teijin phama corp.
Organization
Division
Category of Funding Organization Profit organization
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 久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 25 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 Completed
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 25 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003245

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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