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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010811
Receipt No. R000012653
Scientific Title Acute Effect of Inhaled Budesonide/Formoterol Combination Compared with Terbutaline on Airway Inflammation in Patients with Asthma
Date of disclosure of the study information 2013/05/27
Last modified on 2013/05/27

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Basic information
Public title Acute Effect of Inhaled Budesonide/Formoterol Combination Compared with Terbutaline on Airway Inflammation in Patients with Asthma
Acronym Acute Effect of Inhaled Budesonide/Formoterol on Airway Inflammation in Asthma
Scientific Title Acute Effect of Inhaled Budesonide/Formoterol Combination Compared with Terbutaline on Airway Inflammation in Patients with Asthma
Scientific Title:Acronym Acute Effect of Inhaled Budesonide/Formoterol on Airway Inflammation in Asthma
Region
Asia(except Japan)

Condition
Condition To investigate the effects of budesonide/formoterol on acute anti-inflammation and lung function improvement in patients with asthma
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects budesonide/formoterol on acute anti-inflammation and lung function improvement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of exhaled nitric oxide value, cell counts of eosinophils and inflammatory medicatiors in induced sputum from baseline (time zero)
Key secondary outcomes Change of exhaled nitric acid, FEV1, 5-item asthma control questionnaires status from baseline to end of study (24 weeks)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 budesonide/formoterol (160/4.5 ug/inhalation) 4 inhalations
Interventions/Control_2 budesonide/formoterol (160/4.5 ug/inhalation) 2 inhalations
Interventions/Control_3 turbutaline (0.5 mg/inhlation) 2 inhalations
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients are 20-70 years old of either gender;
2.Patients are diagnosed as having asthma according to GINA guideline;
3.Baseline exhaled nitric oxide (eNO) &sup3; 40 ppb in symptomatic asthma patient;
4.Nonsmoker or current smoker with less than 10 pack/year consumption;
5.Patients are willing and able to comply with study procedures and sign informed consent
Key exclusion criteria 1.Patients take the following medications within 3 months prior to the study enrollment:
&#8226;oral or inhaled glucocorticosteroid;
&#8226;anti-inflammatory treatment;
2.Patients are hypersensitive to budesonide, formoterol, terbutaline or inhaled lactose;
3.Documented evidence of any respiratory infection within 4 weeks prior to enrolment;
4.Females who are lactating or pregnant;
5.Documented evidence of malignancy;
6.Participation in any other clinical trial or using any other investigational drug within 30 days of entry to this protocol;
7.Documented evidence of significant renal function impairment, severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV), or any finding through physical examination or medical history giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Diahn-Warng Perng
Organization Taipei Veterans General Hospital
Division name Depart of Chest Medicine
Zip code
Address No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
TEL 886-2-2871-2121-3194
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kang-Cheng Su
Organization Taipei Veterans General Hospital
Division name Depart of Chest Medicine
Zip code
Address No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
TEL 886-2-28712121-8928
Homepage URL
Email kcsu@vghtpe.gov.tw

Sponsor
Institute Taipei Veterans General Hospital
Institute
Department

Funding Source
Organization AstraZeneca, Taiwan
Organization
Division
Category of Funding Organization Outside Japan
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 Taipei Veterans General Hospital (Taipei)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 27 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
The significant correlations between eosinophils and eNO and between neutrophils and IL-8 were observed at baseline. Six hours after dosing, total eosinophil counts, IL-8 and matrix metalloproteinase-9 were significantly decreased in the group of higher dose of budesonide/formoterol(vs. those with turbutaline group, P < 0.05). The increase in FEV1 in the group of higher dose of budesonide/formoterol was significantly higher comparing to other groups 3 3 hours after dosing. In the following 24 weeks, significant asthma control was achieved in terms of eNO, FEV1, and ACQ-5 4 weeks after treatment, and the improvement was sustained to the end of study.
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 04 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 30 Day
Last follow-up date
2011 Year 02 Month 10 Day
Date of closure to data entry
2011 Year 02 Month 28 Day
Date trial data considered complete
2011 Year 02 Month 28 Day
Date analysis concluded
2012 Year 05 Month 04 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 27 Day
Last modified on
2013 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012653

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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