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The purpose of this study is to determine which treatment is more effective and safer for the patients in COPD C group with bronchiectasis.The research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.
The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. According to the GOLD,there are three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or LABA combined with LAMA. However, it has not yet been demonstrated about which method is more effective for the patients with COPD in group C and bronchiectasis.
This study is designed as a prospective, randomized, case-control trial. Patients are divided into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and (Symbicort).The course of treatment is 12 months.
The investigators will also assess other relevant outcomes, including the quality of life (QOL) score, pulmonary function test and the incidence of adverse event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICS/LABA Group | Active Comparator | Symbicort,Inhalation,Individualized medication,12 months. |
|
| LAMA Group | Active Comparator | Tiotropium Bromide,Inhalation,Individualized medication,12 months. |
|
| LAMA+LABA Group | Active Comparator | Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort | Drug | drug are used for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute exacerbation | The times of acute exacerbation during the trial. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia. | 12 months |
| FEV1 | Forced Expiratory Volume in one second |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Fu Xu | Shanghai Pulmonary Hospital , Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24872685 | Result | Oba Y, Lone NA. Comparative efficacy of inhaled corticosteroid and long-acting beta agonist combinations in preventing COPD exacerbations: a Bayesian network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2014 May 12;9:469-79. doi: 10.2147/COPD.S48492. eCollection 2014. | |
| 24671923 | Result | Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;2014(3):CD010844. doi: 10.1002/14651858.CD010844.pub2. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Spiriva | Drug | drug are used for 12 months |
|
|
| 12 months |
| FVC | Forced Vital Capacity | 12 months |
| FEV1/FVC | Pulmonary function test | 12 months |
| SGRQ | St. George's Respiratory Questionnaire | 12 months |
| LCQ | The Leicester Cough Questionnaire | 12 months |
| CAT | COPD Assessment Test | 12 months |
| mMRC | Modified Medical Research Council Dyspnea Scale | 12 months |
| 24952426 | Result | Manoharan A, Short PM, Anderson WJ, Lipworth BJ. Impact of long-acting bronchodilators and exposure to inhaled corticosteroids on mortality in COPD: a real-life retrospective cohort study. Lung. 2014 Oct;192(5):649-52. doi: 10.1007/s00408-014-9611-8. Epub 2014 Jun 22. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |