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Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

24 oktober 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

76

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år till 80 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Asthma control questionnaire (ACQ)
Tidsram: Change from Baseline ACQ score at 36 months
Asthma control questionnaire (ACQ)
Change from Baseline ACQ score at 36 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Forced expiratory volume in one second
Tidsram: Change from Baseline ACQ score at 36 months
Forced expiratory volume in one second
Change from Baseline ACQ score at 36 months
Airway responsiveness
Tidsram: Change from Baseline ACQ score at 36 months
Airway responsiveness
Change from Baseline ACQ score at 36 months
Peak expiratory flow
Tidsram: Change from Baseline ACQ score at 36 months
Peak expiratory flow
Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire
Tidsram: Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire
Change from Baseline ACQ score at 36 months
Acute asthma episode
Tidsram: Change from Baseline ACQ score at 36 months
Acute asthma episode
Change from Baseline ACQ score at 36 months
Numbers of emergency or hospitalization
Tidsram: Change from Baseline ACQ score at 36 months
Numbers of emergency or hospitalization
Change from Baseline ACQ score at 36 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2015

Primärt slutförande (Faktisk)

12 december 2019

Avslutad studie (Faktisk)

23 oktober 2020

Studieregistreringsdatum

Först inskickad

24 juli 2017

Först inskickad som uppfyllde QC-kriterierna

28 juli 2017

Första postat (Faktisk)

2 augusti 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CTVA-China

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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