UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012046
Receipt number R000014083
Scientific Title Comparison of efficacy in pulmonary function of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD: Multicenter study.
Date of disclosure of the study information 2013/11/01
Last modified on 2016/03/22 16:31:25

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Basic information

Public title

Comparison of efficacy in pulmonary function of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD: Multicenter study.

Acronym

Comparison of efficacy of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD

Scientific Title

Comparison of efficacy in pulmonary function of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD: Multicenter study.

Scientific Title:Acronym

Comparison of efficacy of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the non-inferiority of efficacy of tiotropium / indacaterol versus tiotropium / budesonide / formoterol on pulmonary function in patients with moderate to severe COPD patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement in FEV1 at 24 hours post dose (trough) before and after 8 weeks treatment.

Key secondary outcomes

Improvements in the data of spirometry and IOS at 24 hours post dose (trough) before and after 8 weeks treatment.

CAT score, transition dyspnea index (TDI), MMRC

Exacerbations.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Add indacaterol on tiotropium treatment in COPD patients.

Interventions/Control_2

Add budesonide / formoterol on tiotropium treatment in COPD patients.

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

Smoking history of 10 pack-years or more
Diagnosis of moderate-to-severe COPD
Post bronchodilator FEV1 <80% predicted normal
Post-bronchodilator FEV1 / FVC <70%
Patients treated with tiotropium for more than 2 weeks

Key exclusion criteria

COPD with asthma
Patients who are already treated with ICS or oral corticosteroid regularly
Patients with a history of asthma
Patients who have experienced a COPD exacerbation within the previous 8 weeks.
Patients with uncontrolled cardiac diseases

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masamichi Mineshita

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory and Infectious Diseases

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL

044-977-98111

Email

m-mine@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masamichi Mineshita

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory and Infectious Diseases

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL

044-977-98111

Homepage URL


Email

m-mine@marianna-u.ac.jp


Sponsor or person

Institute

Division of Respiratory and Infectious Diseases, St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

神奈川県立循環器呼吸器病センター(神奈川県)、北里大学病院(神奈川県)、聖マリアンナ医科大学(神奈川県)、昭和大学藤ヶ丘病院(神奈川県)、昭和大学横浜市北部病院(神奈川県)、東海大学医学部内科系呼吸器内科学(神奈川県)、東海大学付属東京病院呼吸器循環器センター(東京都)、横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 01 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


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

Completed

Date of protocol fixation

2013 Year 10 Month 15 Day

Date of IRB


Anticipated trial start date

2013 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

2013 Year 10 Month 16 Day

Last modified on

2016 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name