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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027521
Receipt No. R000031493
Scientific Title Effects of Long-acting muscarinic antagonist(LAMA) and Long-acting beta-two-agonist (LABA) combination on dynamic pulmonary hyperinflation
Date of disclosure of the study information 2017/05/31
Last modified on 2019/03/09

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Basic information
Public title Effects of Long-acting muscarinic antagonist(LAMA) and Long-acting beta-two-agonist (LABA) combination on dynamic pulmonary hyperinflation
Acronym Effect of bronchodilator combination on dynamic pulmonary hyperinflation
Scientific Title Effects of Long-acting muscarinic antagonist(LAMA) and Long-acting beta-two-agonist (LABA) combination on dynamic pulmonary hyperinflation
Scientific Title:Acronym Effect of bronchodilator combination on dynamic pulmonary hyperinflation
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the purpose in this study was performed to elucidate the effects of combined treatment with tiotropium and olodaterol on DLH following hyperventilation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes The primary outcome was defined as decrease in inspiratory capacity (IC) from rest by metronome-paced incremental hyperventilation(MPIH), which is an index of dynamic lung hyperinflation(DLH). after 8 weeks with treatment.
Key secondary outcomes The secondary outcomes were COPD assessment test (CAT), FEV1, and 6-minute walking distance (6MWD). In addition to, as in previous studies, we investigated whether there are correlations between changes by treatment in DLH and exercise tolerance or dyspnea on exercise after 8weeks with treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment was on the day after completion of the baseline examination, and consisted of administration of tiotropium/olodaterol 5/5 micro grum inhalation solution (2.5/2.5 microgram per actuation) by soft-mist inhaler. Patients were instructed to inhale two puffs from the inhaler, once a day, in the morning.

The combination of LAMA and LABA used consisted of Spiolt and Respimat, respectively (Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan), which contained 2.5 microgram of tiotropium and 2.5 microgram of olodaterol per puff, respectively.
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients suffered from smoking-related COPD without alpha 1 antitrypsin deficiency, and those with a smoking history of 10 pack-year or more including current smoker were selected for this study. In addition, as a substitute for LAMA and LABA during the washout period, patients who responded to symptoms with short-acting treatment were selected as eligible for inclusion. After receiving a thorough explanation of the study, patients who provided written consent were enrolled in the study
Key exclusion criteria Patients with dysuria due to prostate hypertrophy, glaucoma, severe heart failure, exacerbation and/or respiratory infection within 3 months, prior history of lung surgery, severe heart disease, or impairment or difficulty in walking due to motor or cognitive dysfunction were excluded. Exacerbation history criteria was defined as an acute worsening of respiratory symptoms that result in additional therapy.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shohei Kawachi
Organization Shinshu University Hospital
Division name Department of Rehabilitation
Zip code
Address 3-1-1, Asahi, Matsumoto, 390-8621, Japan
TEL 0263-37-2836
Email drodman@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohei Kawachi
Organization Shinshu University Hospital
Division name Department of Rehabilitation
Zip code
Address 3-1-1, Asahi, Matsumoto, 390-8621, Japan
TEL 0263-37-2836
Homepage URL
Email drodman@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital,Department of Rehabilitation
Institute
Department

Funding Source
Organization The authors receive financial support by Nihon rehabilitation Shinkokai Foundation, a general incoroprated foundation (Koganei, Tokyo, Japan)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 信州大学医学部附属病院(長野県)、 新生病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 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
Five of the 38 registered patients dropped out of the study. The reasons for dropping out were hospitalization due to gastrointestinal disorder, discontinuation of hospital visits for unknown reasons, refusal to undergo examination after treatment, hospitalization due to exacerbation of respiratory diseases, and did not meet the criteria of COPD after registration into the study in one patient each. All results were not trough values. Because.

Characteristics of patients and comparison of lung functions before and after treatment
The study population included patients with mild to severe disease as determined by classification of airflow limitation severity using %FEV1, 60% of all subjects were moderate disease status. FEV1, %FEV1, and FEV1/FVC (forced vital capacity) ratio were significantly higher after in comparison to before treatment , while CAT was lower after treatment.
Comparison of dynamic lung hyperinflation following metronome-paced incremental hyperventilation (MPIH) and 6MWT before and after treatment
 -IC20, -IC30, and -IC40 were significantly decreased after treatment. IC20, IC30, and IC40 increased significantly after treatment. In addition, deltaIC was significantly decreased after treatment. The 6MWD was significantly increased after treatment.
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 Completed
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 11 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2019 Year 03 Month 09 Day
Date analysis concluded

Other
Other related information Correlation of changes in DLH, FEV1, exercise tolerance, and dyspnea with treatment
There were not significant correlations between changes in each IC, FEV1, 6MWD, and BSmax with treatment.

Management information
Registered date
2017 Year 05 Month 29 Day
Last modified on
2019 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/09 shohei kawachi date 20193009.xlsx


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