UMIN-CTR Clinical Trial

Public title

Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks

Acronym

Effect of ICS/LABA on asthma management

Scientific Title

Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks

Scientific Title:Acronym

Effect of ICS/LABA on asthma management

Region

Japan

Condition

asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We analyzed the relationship between asthma symptoms, including peak expiratory flow rate (PEFR) and adjustment of the dose by the patient.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

asthmatic symptpms and peak expiratory flow rate

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with asthma who are stable at least last 4 weeks.

Key exclusion criteria

Patients who need the corticosteroid excepting the inhale corticosteroid.
Patients with other respiratory diseases, malignant diseases, pregnancy and/or lactation.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Fukuda

Organization

Dokkyo Medical University

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code

Address

880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan

TEL

0282-86-1111

Email

t-fukuda@dokkyomed.ac.jp

Name of contact person

1st name
Middle name
Last name	syomuka

Organization

Dokkyo Medical University

Division name

The ethics committee

Zip code

Address

880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan

TEL

0282-86-1111

Homepage URL

Email

syomuka@dokkyomed.ac.jp

Institute

Dokkyo Medical University

Institute

Department

Personal name

Organization

Dokkyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://asthmarp.biomedcentral.com/articles/10.1186/s40733-018-0043-8

Number of participants that the trial has enrolled

Results

Background
The combination of budesonide + formoterol (BFC) offers the advantages of dose adjustment in a single inhaler according to asthma symptoms. We analyzed the relationship between asthma symptoms in terms of peak expiratory flow (PEF) and dose adjustment by the patient.
Methods
Twenty-eight patients with asthma who used BFC for alleviation of their symptoms (12 men, 16 women; 60 years old) were instructed that the inhaled BFC dose could be increased to a maximum of 8 inhalations per day according to symptom severity. Patients measured and recorded PEF every morning and evening in their asthma diary along with their symptoms and the dose of drugs taken.
Results
Sixteen of the 28 patients increased their dose for asthma symptoms. The time to recovery from the asthma symptoms was significantly shorter when cough was the only symptom present compared with dyspnea or wheeze (1.4 vs. 5.3 or 6.6 days, p？<？0.05) and when they had only one symptom compared with two or three symptoms (1.3 vs. 5.7 or 10.5, p？<？0.01). The relationship between PEF (% of personal best) when the dose was increased (Y) and the days for the increased dose to achieve a PEF greater than PEF in the symptom-free state (X) was determined to be Y？=？-0.591X？+？89.2 (r2？=？0.299, p？<？0.001).

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

01

Month

11

Day

Date of IRB

Anticipated trial start date

2011

Year

01

Month

11

Day

Last follow-up date

2016

Year

04

Month

30

Day

Date of closure to data entry

2016

Year

05

Month

31

Day

Date trial data considered complete

2016

Year

11

Month

30

Day

Date analysis concluded

2017

Year

05

Month

31

Day

Other related information

As a guide for increasing the BFC dose when patients with mild asthma have asthma symptoms, the dose should be increased when cough is present or PEF is decreased to 88.9% (i.e., X？=？0.5).

Registered date

2012

Year

12

Month

21

Day

Last modified on

2018

Year

06

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011259