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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003724
Receipt No. R000004503
Scientific Title Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS
Date of disclosure of the study information 2010/06/08
Last modified on 2010/12/14

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Basic information
Public title Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS
Acronym Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS (EVOLUTION study)
Scientific Title Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS
Scientific Title:Acronym Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS (EVOLUTION study)
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy and safety of ICS/LABA combination therapy in patients with bronchial asthma untreated with inhaled corticosteroid (ICS) and long-acting inhaled beta 2 agonist (LABA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Achievement rate of "well-control" as defined by JGL2009 at 8 weeks after start of treatment period
Key secondary outcomes (1)Efficacy endpoints
- Achievement rate of "well-control" as defined by JGL2009 at 2 weeks after start of treatment period
- Achievement rate of "well-control" as defined by GINA2006 at 2 and 8 weeks after start of treatment period
- Daytime asthmatic symptoms
- Nocturnal asthmatic symptoms and arousal
- Limitation of activities
- Frequency of use of short-acting inhaled beta 2 agonist (SABA)
- %FEV1.0
- ACQ5
- Adherence
- NO in breath
- PEF
(2) Safety endpoints
- Adverse events
- Adverse drug reactions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
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 Symbicort group
Two inhalations of Symbicort Turbuhaler 60, twice daily
Treatment period (8 weeks)
Interventions/Control_2 Pulmicort group
Two inhalations of Pulmicort 200g Turbuhaler 56 (or 112), twice daily
Treatment period (8 weeks)
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

Not applicable
Gender Male and Female
Key inclusion criteria [At start of observation period]
1) Patients who have not used ICS within 3 months before start of observation period
2) Patients who have not used LABA within 1 week before start of observation period
3) Patients presenting with "cough," "wheezing," "dyspnea," or any other symptom that suggests asthma, or those who are diagnosed with asthma by the investigator
4) Nonsmokers and patients who have not smoked for 1 year or longer (if patients have not smoked for 1 year or longer, those with a smoking history of 10 pack-year or more will not be included)
5) Patients aged 20 years or over at the time of informed consent
6) Patients who understand the content of the study and give written consent to participation in the study at their own will
[At start of treatment period]
The following inclusion criteria will be confirmed before start of treatment period:
1) Subjects diagnosed with asthma by the investigator during observation period
2) Subjects presenting with asthmatic symptoms once or more a week during observation period
Key exclusion criteria [At start of observation period]
1) Patients with frequent nocturnal symptoms
2) Patients with limited daily activities
3) Patients who are judged to require oral steroid therapy to control asthmatic symptoms at start of observation period
4) Patients with %FEV1.0 less than 60% at start of period
5) Patients who have used steroid therapy (injection, oral preparation, intestinal infusion, or suppository) within 4 weeks before start of period
6) Patients who have started treatment with any leukotriene receptor antagonist within 2 months before start of period
7) Patients who have any coexisting respiratory infection including tuberculosis or acute upper respiratory tract inflammation/bronchitis, or those who have a history of such infections within 4 weeks before start of period
8) Patients who have any coexisting respiratory disease (COPD, pulmonary fibrosis, etc.) other than asthma
9) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication
10) Patients who have coexisting malignant tumor or a history of malignant tumor
11) Patients who have started new hyposensitization or nonspecific therapy within 3 months before start of period
12) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study
13) Others deemed unsuitable by the investigator
14) Patients who meet any of the contraindications described in the package insert of the study drug
[At start of observation period]
1) Subjects with a body temperature of 37.5 degrees or above that suggests acute upper respiratory tract inflammation/bronchitis during observation period
2) Subjects who have used new asthma therapy other than the pretreatment drug during observation period
3) Subjects who have used steroid therapy (injection, oral preparation, inhalation, intestinal infusion, or suppository) during observation period
4) Others deemed unsuitable by the investigator
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Niimi
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine (Internal Medicine)
Zip code
Address 53, Shogoin-Kawaramachi, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization IAA Study Group
Division name ICS/LABA Combination Therapy Intervention Study Group
Zip code
Address 53, Shogoin-Kawaramachi, Sakyo-ku, Kyoto
TEL 075-751-3830
Homepage URL
Email

Sponsor
Institute IAA Study Group
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan Inc.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 08 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 Open public recruiting
Date of protocol fixation
2010 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 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
2010 Year 06 Month 08 Day
Last modified on
2010 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004503

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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