UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027446 |
|---|---|
| Receipt number | R000031429 |
| Scientific Title | Efficacy of long-acting bronchodilators on dynamic lung hyperinflation in chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2017/05/24 |
| Last modified on | 2017/05/22 17:52:44 |
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Basic information
Public title
Efficacy of long-acting bronchodilators on dynamic lung hyperinflation in chronic obstructive pulmonary disease.
Acronym
Bronchodilator on dynamic hyperinflation
Scientific Title
Efficacy of long-acting bronchodilators on dynamic lung hyperinflation in chronic obstructive pulmonary disease.
Scientific Title:Acronym
Bronchodilator on dynamic hyperinflation
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dynamic lung hyperinflation (DLH) is an important phenomenon that causes dyspnea and restricts exercise capacity in chronic obstructive pulmonary disease (COPD). It has been shown that improvements in dyspnea on effort following bronchodilator therapy correlate well with reductions in lung hyperinflation, as indicated by increases in inspiratory capacity (IC). There are two bronchodilators with different action mechanisms, long-acting muscarinic antagonist (LAMA) and long-acting beta (2)-agonist (LABA). However, little evidence of a difference between LAMA and LABA and an additive effect of LABA with LAMA regarding DLH has been demonstrated. DLH has been generally evaluated based on the size of the reduction in IC measured during or immediately after exercise loading. We have reported a method of quantitatively determining dynamic hyperinflation following hyperventilation in which respiratory rate is incrementally increased without exercise loading (metronome-paced incremental hyperventilation, MPIH) and the resulting change in IC is measured. The purpose is to determine the superiority of the efficacies among the monotherapies of LAMA, tiotropium (Respimat inhaler), and LABA, indacaterol, and the combination therapy of LAMA and LABA for the DLH evaluated by the method of MPIH.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dynamic lung hyperinflation
Key secondary outcomes
FEV1, lung volumes, airway resistance, respiratory impedance, walking distance evaluated by shuttle walking test, health status evaluated by a questionnaire of the COPD assessment test (CAT), activity of daily life (ADL) evaluated using the questionnaire of the pulmonary emphysema activity of daily life score (P-ADL).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The study design is a random open-label crossover study. The subjects are divided into two groups at random for an accurate evaluation of the influence of the order of drug treatments with tiotropium and indacaterol. One group is treated with a 5 microgram once-daily dosage of tiotropium through a soft mist inhaler (Respimat inhaler) for 4 weeks following a 4 week-treatment with a 150 microgram once-daily dosage of indacaterol through a dry powder inhaler, finally, is treated with the combination of the two drugs (tiotropium + indacaterol) for 4 weeks.
Interventions/Control_2
The other group is treated with indacaterol for 4 weeks following a 4-week treatment with tiotropium in the same manner; finally, the other group is treated with the combination of the two drugs (tiotropium + indacaterol) for 4 weeks.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We recruite symptomatic patients with stable COPD from the outpatient clinic of Shinshu University Hospital. COPD is diagnosed based on clinical history and symptoms and by the pulmonary function characterized by irreversible airflow limitation in accordance with the GOLD guidelines. All subjects had smoking-related COPD without alfa1-antitrypsin deficiency and had a smoking history of more than 30 pack-years.
Key exclusion criteria
The patients who have any history of asthma or asthmatic symptoms, walking disability, severe arrhythmia, or heart failure, those who have suffered from respiratory tract infection or exacerbation of COPD during the preceding three months, and those who have been treated with oral steroids and/or long-term oxygen therapy were excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisaku Fujimoto |
Organization
Shinshu University School of Health Sciences
Division name
Department of Clinical Laboratory Sciences
Zip code
Address
3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL
0263-37-2393
keisaku@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisaku Fujimoto |
Organization
Shinshu University School of Health Sciences
Division name
Department of Clinical Laboratory Sciences
Zip code
Address
3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL
0263-37-2393
Homepage URL
keisaku@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Main results already published
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031429
