Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03237221
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
yanfugui, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum Drug: Treat patient according to Global Initiative for Asthma (GINA) guideline

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : December 12, 2017
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Drug: Treat patient according to Global Initiative for Asthma (GINA) guideline
    Treat patient according to Global Initiative for Asthma (GINA) guideline


Primary Outcome Measures :
  1. Asthma control questionnaire (ACQ) [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Asthma control questionnaire (ACQ)


Secondary Outcome Measures :
  1. Forced expiratory volume in one second [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Forced expiratory volume in one second

  2. Airway responsiveness [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Airway responsiveness

  3. Peak expiratory flow [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Peak expiratory flow

  4. Asthma quality of life questionnaire [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Asthma quality of life questionnaire

  5. Acute asthma episode [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Acute asthma episode

  6. Numbers of emergency or hospitalization [ Time Frame: Change from Baseline ACQ score at 36 months ]
    Numbers of emergency or hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237221


Contacts
Layout table for location contacts
Contact: Fugui Yan yfg0726@163.com

  Show 34 Study Locations
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Study Chair: Huahao Shen Second Affiliated Hospital, School of Medicine, Zhejiang University

Layout table for additonal information
Responsible Party: yanfugui, Vice Director,Respiratory and Critical Care Medicine,Clinical Vice Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03237221     History of Changes
Other Study ID Numbers: CTVA-China
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Lung Diseases, Obstructive
Lung Diseases
Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Leukocyte Disorders
Hematologic Diseases