UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008530
Receipt number R000010033
Scientific Title Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.
Date of disclosure of the study information 2012/07/26
Last modified on 2016/02/11 18:29:06

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Basic information

Public title

Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Acronym

Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Scientific Title

Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Scientific Title:Acronym

Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Region

Japan


Condition

Condition

bronchial asthma

Classification by specialty

Pneumology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to compare the effect of budesonide/folmoterol compound and fluticasone/salmeterol compound in association with inspiratory flow.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of %FEV1.0 before and after the therapy for eight weeks.

Key secondary outcomes

Difference in Inspiratory flow and ACQ (Asthma Control Questionnaire) before and after the therapy for eight weeks.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Symbicot(R) 2puff, bid

Interventions/Control_2

Adair(R) 250 1puff,bid

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients matched below.
1. Patients with bronchial asthma.
2. Age >=65
3. Informed consent sheet have already been acquired.
4. %FEV1.0 <= 80% on pulmonary function test.
5. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated only with inhaled corticosteroid.
6. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated with low-dose ICS/LABA compound (Symbicot(R) 2 times/day, Adair(R) 100 2 times/day).
7. Outpatient

Key exclusion criteria

1. Contraindication to budesonide/formoterol or fluticasone /salmeterol compound.
2. High-dose ICS/LABA have already been prescribed (Symbicot(R) inhalation>=6 times/day or Adair(R) 500 inhalation).
3. Respiratory infection in last 4 weeks before enrollment.
4. Beta2 agonist in any form.
5. Systemic corticosteroid therapy in last 30 days before enrollment.
6. Any serious comorbidity.
7. Being or willing to be pregnant
8. Investigator judged as inappropriate for this study.

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Yamaguchi

Organization

The University of Tokyo Hospital

Division name

Department of Geriatric Medicine

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655

TEL

03-5800-8652

Email

yamayasu-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Yamamoto

Organization

Tokyo Metroporitan Geriatric Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

35-2 Sakaecho, Itabashi-ku, Tokyo, Japan 173-0015

TEL

03-3964-1141

Homepage URL


Email

hyamamot-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 26 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

Completed

Date of protocol fixation

2012 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 26 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry

2014 Year 06 Month 30 Day

Date trial data considered complete

2014 Year 06 Month 30 Day

Date analysis concluded

2016 Year 02 Month 11 Day


Other

Other related information



Management information

Registered date

2012 Year 07 Month 25 Day

Last modified on

2016 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name