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

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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 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


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

Value
https://center6.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