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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name