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To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antitumor therapy | All patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles. |
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| Inhaled preparation for COPD | 60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antitumor therapy | Drug | All patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles |
| Measure | Description | Time Frame |
|---|---|---|
| PSF、Time and severity of the first acute exacerbation of severe COPD (AECOPD) | 2 years |
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Inclusion Criteria:
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Exclusion Criteria:
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Patients aged ≥18 years, diagnosed with stage IIIb-Ⅳ primary squamous non-small cell lung cancer, diagnosed as stable moderate to severe chronic obstructive pulmonary disease (COPD), genetic testing showed negative driver genes, ECOG PS 0-2 scores, and prior bronchodilators and inhaled corticosteroids were required to undergo a eluting period of at least 15 days. Patients volunteered to join the program.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHOU | Contact | 13560351186 | doctorzcz@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province | Recruiting | Guangzhou | Guangdong | 510163 | China |
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|
| Inhaled preparation for COPD | Drug | 60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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