- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03237221
Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
24. oktober 2020 opdateret af: yanfugui, Second Affiliated Hospital, School of Medicine, Zhejiang University
Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health.
Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning.
However, there are still some patients with only persistent clinical manifestations of chest tightness.
Concerned about this group of patients, we presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA).
This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time.
In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA.
Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype.
Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
76
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina
- China-Japan Friendship Hospital
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Beijing, Beijing, Kina
- Beijing tongren Hospital, Capital Medical University
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Beijing, Beijing, Kina
- Beijing Chao-Yang Hospital
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Chongqing
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Chongqing, Chongqing, Kina
- Xinqiao Hospital,Third Military Medical University
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Fujian
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Fuzhou, Fujian, Kina
- The Second Affiliated Hospital,Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Kina
- The First Affiliated Hospital,Guangzhou Medical University
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Guangzhou, Guangdong, Kina
- Nanfang Hospital, Nanfang Medical University
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Shenzhen, Guangdong, Kina
- People's Hospital of Shenzhen
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Zhanjiang, Guangdong, Kina
- Affiliated Hospital,Zhanjiang Medical College
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Guizhou
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Guiyang, Guizhou, Kina
- Guizhou Provincial People's Hospital
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Henan
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Zhengzhou, Henan, Kina
- Henan Provincial People's Hospital
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Hubei
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Wuhan, Hubei, Kina
- Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, Kina
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Kina
- Jiangsu Province Hospital
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Liaoning
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Shenyang, Liaoning, Kina
- The Central Hospital of Shenyang Military
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Shenyang, Liaoning, Kina
- The First Affiliated Hospital, China Medical University
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Shaanxi
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Xi'an, Shaanxi, Kina
- Xijing Hospital
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Shandong
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Jinan, Shandong, Kina
- Qilu Hospital, Shandong University
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Jinan, Shandong, Kina
- Shandong Provincal Hospital
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Qingdao, Shandong, Kina
- Qingdao Municipal Hospital
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Weifang, Shandong, Kina
- Weifang Asthma Hospital
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Yantai, Shandong, Kina
- Yantai liuhuanding Hospital
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Shanghai
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Shanghai, Shanghai, Kina
- Zhongshan Hospital, Fudan University
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Shanghai, Shanghai, Kina
- Changhai Hospital, Second Military Medical University
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Shanghai, Shanghai, Kina
- Ruijin Hospital, Shanghai Jiaotong University
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Shanghai, Shanghai, Kina
- No.1 Hospital, Shanghai Jiaotong University
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Shanghai, Shanghai, Kina
- Tongji Hospital, Tongji University
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Shanghai, Shanghai, Kina
- Xinhua Hospital, Shanghai Jiaotong University
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Sichuan
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Chengdu, Sichuan, Kina
- West China Hospital,Sichuan University
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Sir Run Run Shaw hospital, College of Medicine,Zhejiang University
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Hanzhou, Zhejiang, Kina, 310000
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Huzhou, Zhejiang, Kina
- Huzhou Central Hospital
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Wenzhou, Zhejiang, Kina
- The Second Affiliated Hospital,Wenzhou Medical University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
Beskrivelse
Inclusion Criteria:
- all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
- the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
- the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
- no wheezing;
a diagnosis of asthma supported by one or more other characteristics:
- bronchial provocation test positive;
- improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;
- variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.
- bronchodilator and glucocorticoid treatment is effective;
- exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.
Exclusion Criteria:
- can not cooperate with related inspection or for other reasons;
- patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);
- history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;
- taking part in other drug clinical trial project, or drop out less than 3 months;
- during pregnancy, lactation women;
- obvious abnormal of High Resolution CT.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Asthma control questionnaire (ACQ)
Tidsramme: Change from Baseline ACQ score at 36 months
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Asthma control questionnaire (ACQ)
|
Change from Baseline ACQ score at 36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Forced expiratory volume in one second
Tidsramme: Change from Baseline ACQ score at 36 months
|
Forced expiratory volume in one second
|
Change from Baseline ACQ score at 36 months
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Airway responsiveness
Tidsramme: Change from Baseline ACQ score at 36 months
|
Airway responsiveness
|
Change from Baseline ACQ score at 36 months
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Peak expiratory flow
Tidsramme: Change from Baseline ACQ score at 36 months
|
Peak expiratory flow
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Change from Baseline ACQ score at 36 months
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Asthma quality of life questionnaire
Tidsramme: Change from Baseline ACQ score at 36 months
|
Asthma quality of life questionnaire
|
Change from Baseline ACQ score at 36 months
|
Acute asthma episode
Tidsramme: Change from Baseline ACQ score at 36 months
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Acute asthma episode
|
Change from Baseline ACQ score at 36 months
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Numbers of emergency or hospitalization
Tidsramme: Change from Baseline ACQ score at 36 months
|
Numbers of emergency or hospitalization
|
Change from Baseline ACQ score at 36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Huahao Shen, Second Affiliated Hospital, School of Medicine, Zhejiang University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2015
Primær færdiggørelse (Faktiske)
12. december 2019
Studieafslutning (Faktiske)
23. oktober 2020
Datoer for studieregistrering
Først indsendt
24. juli 2017
Først indsendt, der opfyldte QC-kriterier
28. juli 2017
Først opslået (Faktiske)
2. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTVA-China
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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