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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012330
Receipt No. R000014415
Scientific Title A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of device of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Date of disclosure of the study information 2018/11/18
Last modified on 2014/11/21

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Basic information
Public title A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of device of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Acronym Study on the efficacy of a fixed-dose combination of fluticasone propionate and formoterol fumarate hydrate (Flutiform)
Scientific Title A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of device of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Scientific Title:Acronym Study on the efficacy of a fixed-dose combination of fluticasone propionate and formoterol fumarate hydrate (Flutiform)
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects and device maneuverability of fluticasone/formoterol pMDI (Flutiform) and fluticasone/salmeterol DPI (Adoair Diskus) in patients who have an inadequate response to current long-term management therapies for asthma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of FEV1 at week 2
Key secondary outcomes - ACQ
- %FEV1, FEV1%, FEV1
- PEF
- FeNO
- Scores for Leicester Cough Questionnaire
- Number of days when therapeutic drugs for asthma attacks are used, number of days when asthma symptoms are present, and asthma symptom score
- Symptom score for cough
- Questionnaire scores on inhaler (device maneuverability)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair Diskus 100 (1 inhalation, 2 times/day) in a 1:1 allocation. The patients assigned to Flutiform 50 Aerosol will be treated with the drug for 2 weeks.
Interventions/Control_2 Patients will be randomly assigned to either Flutiform 50 Aerosol (2 inhalations, 2 times/day) or Adoair Diskus 100 (1 inhalation, 2 times/day) in a 1:1 allocation. The patients assigned to Adoair Diskus 100 will be treated with the drug for 2 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Outpatients
(2) Patients in Step 2 or higher in treatment described in Asthma Prevention and Management Guideline 2012
(3) Patients with inadequately or poorly controlled asthma with existing therapies (see Asthma Prevention and Management Guideline 2012)
(4) Patients who have been receiving Flutide Diskus (200 micro g/dose, 2 times/day) 4 weeks or longer
(5) Patients who have experienced asthma symptoms such as aggravated cough and wheezing or had an emergency hospital visit within the past 1 year
(6) Patients who voluntary provide written informed consent form after having been fully informed about and understand the requirements of study participation
Key exclusion criteria (1) Patients who have experienced adverse drug reactions caused by treatment with an ICS, LABA, or concomitant use or a combination of ICS and LABA
(2) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease
(3) Patients with complications of apparent chronic obstructive pulmonary disease (COPD)
(4) Patients with complications of malignant tumors
(5) Patients with a history of smoking within the past 1 year
(6) Patients who are pregnant, lactating, or desire to conceive during the study period
(7) Patients who were judged unsuitable for enrollment in the study by the investigator or the sub-investigator
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kamei
Organization Kamei Internal Medicine and Respiratory Clinic
Division name Medical director
Zip code
Address 3007-4, Otashimomachi, Takamatsu-shi, Kagawa
TEL 087-866-5001
Email jimukyoku@medical-bs24.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yabe
Organization Bell Medical Solutions Inc
Division name Clinical Research Group, Clinical Research and Development Division
Zip code
Address Tokyu Bldg. East No. 3, 2-16-8, Minami Ikebukuro, Toshima-ku, Tokyo
TEL 0120-313-626
Homepage URL
Email jimukyoku@medical-bs24.com

Sponsor
Institute KYORIN Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization KYORIN Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 亀井内科呼吸器科医院(香川県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 18 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 09 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 19 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 11 Month 18 Day
Last modified on
2014 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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