UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008912
Receipt number	R000010451
Scientific Title	A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy
Date of disclosure of the study information	2012/10/01
Last modified on	2014/12/10 10:16:51

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Basic information

Public title

A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To compare the efficacies of step-down and step-up therapies using budesonide/formoterol combination in patients with poorly controlled asthma after inhaled corticosteroid monotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Percentage of the number of days on which asthma is well controlled in the patients during the entire treatment period

Key secondary outcomes

(1) The outcomes after 12 and 24 weeks of treatment are as follows:
* Change in the results of respiratory function tests from the ones obtained before treatment
* Change in exhaled nitric oxide level from that before treatment
* Change in respiratory resistance from the pretreatment observation
(2) The parameters analyzed during the entire treatment period are as follows:
* Asthma symptom scores for daytime and nighttime
* Asthma Control Questionnaire score
* Frequency of use of relievers in daytime and nighttime
* Total number of weeks in which well-controlled asthma status is achieved
* Episodes of nocturnal awaking due to asthma symptoms
* Adherence to study drug consumption in the morning and evening
(3) Adverse event

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Step-down therapy group:
Initially, budesonide/formoterol combination will be administered at the dosage of 2 inhalations twice a day (bid) for 12 weeks. If asthma is well controlled, the dosage will be changed to 1 inhalation bid. However, if asthma is not well controlled, the dosage will be changed to 4 inhalations bid. The drug will be then administered for the subsequent 12 weeks.

Interventions/Control_2

Step-up therapy group:
Initially, budesonide/formoterol combination is administrated at the dose of 1 inhalation b.i.d. for 12 weeks. If their asthma becomes uncontrolled, the dose is changed to 2 inhalations b.i.d, and if well-controlled, the dose is not changed. Then, the drug is administrated for the subsequent 12 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

* Male and female outpatients, who are aged at least 20 years
* Treatment with inhaled corticosteroid at a dosage equivalent to 400 to 800 mcg/day or a lower dose of budesonide for at least 4 weeks, immediately before the patients are enrolled
* Patients with poorly controlled asthma
* Those who can provide written consent

Key exclusion criteria

* Patients with a history of hypersensitivity to components of budesonide/formoterol combination (including contact dermatitis)
* Patients with an infectious disease or deep mycosis, both of which cannot be treated effectively by any antimicrobial drug
* Patients with tuberculosis
* Patients with a history of usage of long-acting beta agonist or some drug containing a long-acting beta agonist within 4 weeks before enrollment
* Patients with a respiratory infectious disease that affects asthma; onset of the infection should have occurred within 4 weeks before enrollment
* Patients receiving beta-blocker, including an eye drop
* Patients who are administered a systemic steroid within 30 days before enrollment
* Patients with a clinically serious comorbidity
* Patients with FEV1 values less than 60% of the predicted value
* Smokers or patients with a smoking history of more than 10 pack-years, or a former smoker who stopped smoking in the 6 months before enrollment
* Patients who are planning to become pregnant, or who are pregnant, or are breast-feeding
* Those who cannot provide a written informed consent by themselves
* Those concluded to be ineligible by the investigator

Target sample size

100

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takashi Iwanaga

Organization

Kinki University, Faculty of Medicine

Division name

Department of Respiratory Medicine and Allergology

Zip code

Address

377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan

TEL

072-366-0221

Email

crs@mcp.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Takashi Iwanaga

Organization

Kinki University, Faculty of Medicine

Division name

Department of Respiratory Medicine and Allergology

Zip code

Address

377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan

TEL

072-366-0221

Homepage URL

Email

crs@mcp.co.jp

Sponsor or person

Institute

Kinki Respiratory and Allergy Diseases Research Group

Institute

Department

Personal name

Funding Source

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

近畿大学医学部附属病院（大阪府）
近畿大学医学部奈良病院（奈良県）
近畿大学医学部堺病院（大阪府）
橋本市民病院（大阪府）

Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 01 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

No longer recruiting

Date of protocol fixation

2012 Year 08 Month 24 Day

Date of IRB

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2015 Year 05 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 09 Month 13 Day

Last modified on

2014 Year 12 Month 10 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010451