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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test preparation:Methylcholine chloroacetate for inhalation | Experimental | Inhale different concentrations of choline chloride solution |
|
| Reference preparation:Methylcholine chloroacetate for inhalation(Provocholine) | Active Comparator | Inhale different concentrations of choline chloride solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test preparation:Methylcholine chloroacetate for inhalation | Drug | Cholinergic agonists |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline | Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline | 30 to 90 seconds after administration |
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Inclusion Criteria:
4. Patients who use contraindicated drugs (β2 adrenergic receptor agonists, anticholinergics, oral bronchodilators, antihistamines, leukotriene receptor antagonists) may be discontinued during the prescribed period prior to airway reactivity examination.
5, voluntary enrollment, signed informed consent, compliance is good, can cooperate with the test observation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Yang, Doctor | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Reference preparation:Methylcholine chloroacetate for inhalation(Provocholine) | Drug | Cholinergic agonists |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |