Efficacy and Safety of Tuo-Min-Ding-Chuan Decoction on Mild Allergic Asthma: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Center Trial
- Conditions
- Allergic asthma
- Registration Number
- ITMCTR2200005590
- Lead Sponsor
- The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Study participants must meet the diagnostic criteria of AA (Lommatzsch et al., 2020).
(1)Typical symptoms, triggers, and disease course; typical response to steroid therapy.
(2)Lung function test (bodyplethysmography or spirometry): Evidence of at least partially reversible airway obstruction and/or bronchial hyperresponsiveness.
(3)Allergy-related investigation: Specific allergy-related history and skin prick test or measurement of specific serum IgE; total serum IgE; allergen provocation test if appropriate.
(4)Biomarker measurement: Evidence of increased eosinophils in blood and/or raised FeNO:
i: Increase in eosinophils (=150 cell/µL blood or =2% in sputum) ;
ii: Increased exhalation of nitric oxide: increased fraction of exhaled NO, FeNO, measured in parts per billion (= 20 ppb).
2. The participants must be in mild allergic asthma: controlled well by the Step 1 or 2 treatment (Global Initiative for Asthma, 2020).
(1)The Step 1 recommendations are for:
i: Initial asthma treatment in patients with symptoms less than twice a month and no exacerbation risk factors;
ii: Step-down treatment for patients whose asthma is well-controlled on Step 2 treatment.
(2)The step 2 recommendations are for: asthma treatment in patients with symptoms twice a month or more, but less than daily.
3. The participants must be between 18 and 75 years old.
4. The participant must sign informed consent forms.
1.Patients with chronic obstructive pulmonary disease (COPD), bronchiectasis and allergic bronchopulmonary aspergillosis (ABPA).
2. With a history of the ingredients of TMDCD allergies or being allergic to the budesonide-formoterol.
3. Patients had received systematic allergen-specific immunotherapy within one year before enrollment.
4. Patients with a malignant tumor, hematological disease, mental illness, or severe hepatorenal insufficiency.
5. Pregnancy, ready to be pregnant or lactating patients.
6. Unable to complete the tests, such as lung function, FeNO, blood routine, etc.
7. Participate in other clinical studies at the same time.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the total dose of budesonide-formoterol and Total Asthma Symptom Score;The total dose of budesonide-formoterol;
- Secondary Outcome Measures
Name Time Method The total dose of cetirizine hydrochloride;Asthma Quality of Life Questionnaire;Peripheral blood eosinophil count;The fraction of exhaled nitric oxide;Times of AA exacerbation;lung function testing;Constitution in Chinese medicine questionnaire;IgE and sIgE;Asthma Control Test;