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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012876
Receipt No. R000015044
Scientific Title The Epidemiology survey about the asthma to be complicated with chronic obstructive pulmonary disease (COPD) patients
Date of disclosure of the study information 2014/01/16
Last modified on 2014/12/01

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Basic information
Public title The Epidemiology survey about the asthma to be complicated with chronic obstructive pulmonary disease (COPD) patients
Acronym The Epidemiology survey about the asthma to be complicated with chronic obstructive pulmonary disease (COPD) patients
Scientific Title The Epidemiology survey about the asthma to be complicated with chronic obstructive pulmonary disease (COPD) patients
Scientific Title:Acronym The Epidemiology survey about the asthma to be complicated with chronic obstructive pulmonary disease (COPD) patients
Region
Japan

Condition
Condition chronic obstructive pulmonary disease(COPD)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This survey is intended for COPD that requires epidemiological investigation and is a pilot study designed to determine the rate of the complications of asthma based on the presence of allergic rhinitis which is an important risk factor for asthma.
(The study further evaluates the relationship between asthma and other factors [sex, age, severity of COPD]. In so doing, the study grasps the degree of the complications of asthma in COPD patients who have allergic rhinitis which is a major risk factor and obtains data useful for proper diagnosis and treatment of COPD in the elderly.)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Complications of asthma based on the presence of allergic rhinitis among COPD patients under treatment
Key secondary outcomes Relationship between sex, age, and severity of COPD

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)COPD-diagnosed patients in a stable state undergoing treatment for more than 3 months
2)Patients to whom spirometry and airway hyperresponsiveness test can be administered
3)Those who agree to participate by their free will with written consent after understanding the content of the survey
Key exclusion criteria 1)Occasional bloody sputum
2)History of pneumothorax
3)History of heart attack (arrhythmia, anginal pain, etc.)
4)Nausea
5)Occasional cyanosis and severe dyspnea
6)Currently in acute advanced stage of respiratory symptoms
7)History of aneurysm (in the lung, brain, etc.)
8)History of eye surgery (for cataract) within 1 year
9)History of thoracic or gastric surgery within 1 year
10)Presence of tuberculosis (currently active) or obvious sequelae of tuberculosis
11)History of lung cancer
12)History of lung resection
13)History of cystic fibrosis or other pulmonary fibrosis
14)Difficulty in the administration of spirometry
15)Impossibility to perform the airway hyperresponsiveness test due to any of the following reasons:
- FEV1 <1,500 mL or FEV1 <60% PV
- Patients with anginal pain or cerebral apoplexy within 3 months
- Patients with uncontrollable hypertension (systolic >200 mm Hg, diastolic >100 mm Hg)
- Patients with aortic aneurysm
- Patients with pregnancy
- Patients with difficulty to perform spirometry procedure
- Patients under the medication of an AChE inhibitor (severe myasthenia)
16)Patients whom the attending doctor decides not suitable for the entry of the study.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Iwanaga
Organization Kinki University Hospital, Faculty of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 377-2 Ono-Higashi Osakasayama-City Osaka, 589-8511 Japan
TEL 072-366-0221
Email iwanaga@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Iwanaga
Organization Kinki University Hospital, Faculty of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 377-2 Ono-Higashi Osakasayama-City Osaka, 589-8511 Japan
TEL 072-366-0221
Homepage URL
Email iwanaga@med.kindai.ac.jp

Sponsor
Institute Kinki University Hospital, Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kinki-University Sakai Hospital, Faculty of Medicine
Kinki University Nara Hospital, Faculty of Medicine
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 近畿大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 16 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Complications of asthma based on the presence of allergic rhinitis among COPD patients under treatment

Management information
Registered date
2014 Year 01 Month 16 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015044

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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