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Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

24. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

76

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • China-Japan Friendship Hospital
      • Beijing, Beijing, Kina
        • Beijing Tongren Hospital, Capital Medical University
      • Beijing, Beijing, Kina
        • Beijing Chao-Yang Hospital
    • Chongqing
      • Chongqing, Chongqing, Kina
        • Xinqiao Hospital，Third Military Medical University
    • Fujian
      • Fuzhou, Fujian, Kina
        • The Second Affiliated Hospital，Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • The First Affiliated Hospital,Guangzhou Medical University
      • Guangzhou, Guangdong, Kina
        • Nanfang Hospital, Nanfang Medical University
      • Shenzhen, Guangdong, Kina
        • People's Hospital of Shenzhen
      • Zhanjiang, Guangdong, Kina
        • Affiliated Hospital,Zhanjiang Medical College
    • Guizhou
      • Guiyang, Guizhou, Kina
        • Guizhou Provincial People's Hospital
    • Henan
      • Zhengzhou, Henan, Kina
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, Kina
        • Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Kina
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, Kina
        • Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Jiangsu Province Hospital
    • Liaoning
      • Shenyang, Liaoning, Kina
        • The Central Hospital of Shenyang Military
      • Shenyang, Liaoning, Kina
        • The First Affiliated Hospital, China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, Kina
        • Xijing Hospital
    • Shandong
      • Jinan, Shandong, Kina
        • Qilu Hospital, Shandong University
      • Jinan, Shandong, Kina
        • Shandong Provincal Hospital
      • Qingdao, Shandong, Kina
        • Qingdao Municipal Hospital
      • Weifang, Shandong, Kina
        • Weifang Asthma Hospital
      • Yantai, Shandong, Kina
        • Yantai liuhuanding Hospital
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Zhongshan Hospital, Fudan University
      • Shanghai, Shanghai, Kina
        • Changhai Hospital, Second Military Medical University
      • Shanghai, Shanghai, Kina
        • Ruijin Hospital, Shanghai Jiaotong University
      • Shanghai, Shanghai, Kina
        • No.1 Hospital, Shanghai Jiaotong University
      • Shanghai, Shanghai, Kina
        • Tongji Hospital, Tongji University
      • Shanghai, Shanghai, Kina
        • Xinhua Hospital, Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, Kina
        • West China Hospital,Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
      • Hanzhou, Zhejiang, Kina, 310000
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Huzhou, Zhejiang, Kina
        • Huzhou Central Hospital
      • Wenzhou, Zhejiang, Kina
        • The Second Affiliated Hospital,Wenzhou Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 80 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.

Beskrivelse

Inclusion Criteria:

  1. all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
  2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
  3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
  4. no wheezing;

  5. 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.
  6. bronchodilator and glucocorticoid treatment is effective;
  7. exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.

Exclusion Criteria:

  1. can not cooperate with related inspection or for other reasons;
  2. 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);
  3. 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;
  4. taking part in other drug clinical trial project, or drop out less than 3 months;
  5. during pregnancy, lactation women;
  6. obvious abnormal of High Resolution CT.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Asthma control questionnaire (ACQ)
Tidsramme: Change from Baseline ACQ score at 36 months
Asthma control questionnaire (ACQ)
Change from Baseline ACQ score at 36 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Airway responsiveness
Tidsramme: Change from Baseline ACQ score at 36 months
Airway responsiveness
Change from Baseline ACQ score at 36 months
Peak expiratory flow
Tidsramme: Change from Baseline ACQ score at 36 months
Peak expiratory flow
Change from Baseline ACQ score at 36 months
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
Acute asthma episode
Change from Baseline ACQ score at 36 months
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Etterforskere

  • Studiestol: Huahao Shen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2015

Primær fullføring (Faktiske)

12. desember 2019

Studiet fullført (Faktiske)

23. oktober 2020

Datoer for studieregistrering

Først innsendt

24. juli 2017

Først innsendt som oppfylte QC-kriteriene

28. juli 2017

Først lagt ut (Faktiske)

2. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CTVA-China

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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