UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks
Title of the study (Brief title)	Effect of ICS/LABA on asthma management
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	asthmatic symptpms and peak expiratory flow rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Takeshi Fukuda
Organization	Dokkyo Medical University
Division name	Department of Pulmonary Medicine and Clinical Immunology
Address	880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL	0282-86-1111
Email	t-fukuda@dokkyomed.ac.jp

Public contact
Name of contact person	syomuka
Organization	Dokkyo Medical University
Division name	The ethics committee
Address	880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL	0282-86-1111
Homepage URL
Email	syomuka@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://asthmarp.biomedcentral.com/articles/10.1186/s40733-018-0043-8
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).
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).

Management information
Registered date	2012 Year 12 Month 21 Day
Last modified on	2018 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011259