UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012876
Receipt number 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 10:24:00

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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 or person

Institute

Kinki University Hospital, Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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