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Phrase: IV
Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)
Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium bromide for relieving dyspnea symptom of COPD
Design: a multi-centre randomized parallel blank control study
Case number: test group 80, control group 80, totally 160
Site number:7
Study period: 2010.9 - 2011.8
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tulobuterol combined with tiotropium bromide | Experimental |
| |
| Tiotropium bromide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tulobuterol | Drug | patch, 2mg, qN, 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFT values (pulmonary function test, see description below) | IC (inspiratory capacity) 、PEF (peak expiratory flow)、FVC (forced vital capacity)、FEV1 (forced expiratory volume in the first second)、%FEV1 (forced expiratory volume in the first second as predicted)、RV (residual volume)、TLC (total lung capacity)、RV/TLC% (residual volume/total lung capacity as percentage), etc. | 3 months |
| MRC (Medical Research Council) grade | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| SGRQ (St. George's questionnaire) score | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunxue Bai, doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| Tiotropium Bromide |
| Drug |
18ug, inhale, qD, 3 months |
|
| tiotropium bromide | Drug | 18ug, inhale, qD, 3 months |
|
| 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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| ID | Term |
|---|---|
| C010809 | tulobuterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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