UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041342 |
|---|---|
| Receipt number | 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 19:57:40 |
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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
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/
muraki-m@med.kindai.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergology, Kindai University Nara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047175
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| Registered date | File name |
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