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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
