UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Title of the study (Brief title)	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	Hisamichi Aizawa
Organization	Kurume University School of Medicine
Division name	Department of Medicine, Division of Respirology, Neurology, and Rheumatology
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	Tomotaka Kawayama
Organization	Kurume University School of Medicine
Division name	Department of Medicine, Division of Respirology, Neurology, and Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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