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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041342
Receipt No. R000047175
Scientific Title AA randomized prospective controlled trial of long-acting muscarinic antagonist and long-acting be-ta2 agonist fixed dose combinations in patients with chronic obstructive pulmonary disease: Effects on quality of life and pulmonary function and preference
Date of disclosure of the study information 2020/08/06
Last modified on 2020/08/06

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Basic information
Public title A randomized prospective controlled trial of long-acting muscarinic antagonist and long-acting be-ta2 agonist fixed dose combinations in patients with chronic obstructive pulmonary disease: Effects on quality of life and pulmonary function and preference
Acronym A randomized prospective controlled trial of long-acting muscarinic antagonist and long-acting be-ta2 agonist fixed dose combinations in patients with chronic obstructive pulmonary disease
Scientific Title AA randomized prospective controlled trial of long-acting muscarinic antagonist and long-acting be-ta2 agonist fixed dose combinations in patients with chronic obstructive pulmonary disease: Effects on quality of life and pulmonary function and preference
Scientific Title:Acronym A randomized prospective controlled trial of long-acting muscarinic antagonist and long-acting be-ta2 agonist fixed dose combinations in patients with chronic obstructive pulmonary disease
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In chronic obstructive pulmonary disease (COPD) patients, combination treatment with long-acting muscarinic antagonist (LAMA) and long-acting be-ta2 agonist (LABA) increases forced expiratory volume in one second (FEV1) and reduces symptoms compared to monotherapy. In Japan, three different once-daily fixed-dose combinations (FDCs) have been prescribed since 2015, although a direct comparison of these FDCs has never been performed. The objective of the present study was to compare the effectiveness, preference, and safety of three LAMA/ LABA FDCs - glycopyrronium/ indacaterol (Gly/ Ind), umeclidinium/ vilanterol (Ume/ Vil), and tiotropium/ olodaterol (Tio/ Olo) - in patients with COPD.
Basic objectives2 Others
Basic objectives -Others The relationship between the medication selected as the first rank and the background factors of the patients (sex, age, height, weight, BMI, PIF, respiratory function, presence or absence of asthma complication, types of inhalation device at baseline, presence or absence of ICS use, and order of LAMA/ LABA FDCs) were investigated.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Differences in preference, QoL, respiratory function, and adverse events among three medications
Key secondary outcomes The relationship between the medication selected as the first rank in the final comparative questionnaire and the background factors of the patients

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 glycopyrronium/ indacaterol (Gly/ Ind; Ultibro),
once daily for 4 weeks
Interventions/Control_2 umeclidinium/ vilanterol (Ume/ Vil; Anoro),
once daily for 4 weeks
Interventions/Control_3 tiotropium/ olodaterol (Tio/ Olo; Spiorto),
once daily for 4 weeks
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
40 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria COPD patients obtained informed consent
Key exclusion criteria Inability to inhale unassisted; inability to perform spirometry tests; pregnancy; severe comorbidities affecting quality of life, including malignancy, cardiac failure, renal failure, or severe liver dysfunction; and comorbidity of severe prostatic hypertrophy and closed-angle glaucoma.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Muraki
Organization Kindai University Nara Hospital
Division name Department of Respiratory Medicine and Allergology
Zip code 630-0293
Address 1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL 0743-77-0880
Email muraki-m@med.kindai.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Muraki
Organization Kindai University Nara Hospital
Division name Department of Respiratory Medicine and Allergology
Zip code 630-0293
Address 1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL 0743-77-0880
Homepage URL https://www.kindainara.com/
Email muraki-m@med.kindai.ac.jp

Sponsor
Institute Department of Respiratory Medicine and Allergology, Kindai University Nara Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Medicine and Allergology, Kindai University Nara Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kindai University Nara Hospital
Address 1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
Tel 0743-77-0880
Email muraki-m@med.kindai.ac.jp

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 近畿大学奈良病院

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 06 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 75
Results No significant differences in CAT or mMRC were reported, and no significant difference in FEV1 was observed. Although FVC was higher after Ume/ Vil and Tio/ Olo administration, and MMF and V25 were higher after Gly/Ind administration, the differences reported were small. In the final comparative questionnaire survey, patients reported better actual feeling of being able to inhale following Gly/ Ind administration, although no significant differences in adverse events or other evaluations were reported.
Results date posted
2020 Year 08 Month 06 Day
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
2017 Year 01 Month 17 Day
Date of IRB
2017 Year 01 Month 18 Day
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
2019 Year 10 Month 24 Day
Date of closure to data entry
2019 Year 10 Month 24 Day
Date trial data considered complete
2020 Year 08 Month 01 Day
Date analysis concluded
2020 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2020 Year 08 Month 06 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047175

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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