UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024257 |
|---|---|
| Receipt number | R000027928 |
| Scientific Title | Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD |
| Date of disclosure of the study information | 2016/10/10 |
| Last modified on | 2021/10/06 11:19:48 |
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Basic information
Public title
Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD
Acronym
Changes in lung function and physical activity by LAMA/LABA therapy in COPD
Scientific Title
Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD
Scientific Title:Acronym
Changes in lung function and physical activity by LAMA/LABA therapy in COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial is aimed to assess the association of changes in dyspnea, lung function, and physical activity by bronchodilation therapy in patients with COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objective of this trial is to investigate the change in PA over a 12-week in response to QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)) therapy in patients with COPD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent must be obtained before any assessment is performed
2) Aged >=40 years with mild-to-moderate stable COPD
3) A post-bronchodilator FEV1 of >=50% of the predicted normal, have a post-bronchodilator FEV1 to FVC ratio of <0.70
4) Either current smokers or ex-smokers with a smoking history of >=10 pack-years
5) A modified Medical Research Council (mMRC) dyspnea scale grade of at least 1
Key exclusion criteria
1) Moderate-to-severe COPD exacerbation (requiring antibiotics, systemic steroids or hospitalization) within the 4 weeks before the screening
2) Requiring LABA and LAMA combination therapy
3) Requiring long-term oxygen therapy
4) Requiring short-acting beta2-agonista (SABA) relief use of more than 8 puffs/day
5) Concomitant pulmonary disease including asthma (FeNO<50ppb at baseline)
6) Any physical disorder that would prevent the patient from being able to complete the assessments
7) Long QT syndrome at screening, or a clinically significant electrocardiogram abnormality
8) History of closed angle glaucoma, and/or ischuria due to prostatic disease
9) There is a history of hypersensitivity to components of the Urutiburo
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Matsunaga |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Respiratory Medicine and Infectious Disease
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-85-3123
kokyuki@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Matsunaga |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Respiratory Medicine and Infectious Disease
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-85-3123
Homepage URL
kokyuki@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Novartis pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Yamaguchi University
Address
Minami-kogushi 1-1-1, Ube
Tel
+81836853123
kazmatsu@yamaguchi-u.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 10 | 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
45
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
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027928
