UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010811 |
|---|---|
| Receipt number | 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 14:49:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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) ³ 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:
•oral or inhaled glucocorticosteroid;
•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
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
kcsu@vghtpe.gov.tw
Sponsor or person
Institute
Taipei Veterans General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012653
