Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: tulobuterol
* Drug: Tiotropium Bromide
* Drug: tiotropium bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people aging from 40 to 80 with self ability of judgment out-patients diagnosed as stable COPD according to diagnosing and treatment guideline of COPD (2007 edition) by Respiratory Department of Chinese Medical Association PFT value at screen phase meet the standard as follows: FEV1/FVC < 70% and FEV1% among 30%-80% 15 mins after inhalation of 400ug Ventolin (i.e., moderate and severe COPD patients ). people who can use Tiotropium Bromide powder inhalation device people who join the study voluntarily and sign ICF (Informed Consent Form) Exclusion Criteria: people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma AECOPD （acute exacerbation of COPD） people who got respiratory failure 1 month before the study people who received oral corticoid treatment 1 month before the study people who undergo oxygen therapy at home because of respiratory failure people who are allergic to β2 receptor agonist such as tulobuterol patients with Skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist patients who have undergone pulmonary lobectomy or have tumor active tuberculosis patients people who got acute respiratory tract infection in a month or during screening phase allergic rhinitis patients glaucoma patients people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion gestation, lactation and child-bearing age women who don't agree to take contraceptive measures during the study people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases. People who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire. People who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components. people who have taken part in other medical clinical trial other conditions that investigators think not appropriate for the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tulobuterol combined with tiotropium bromide<br> | Drug: tulobuterol<br>* patch, 2mg, qN, 3 months<br>Drug: tiotropium bromide<br>* 18ug, inhale, qD, 3 months<br>|
| Active Comparator: Tiotropium bromide<br> | Drug: Tiotropium Bromide<br>* 18ug, inhale, qD, 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGRQ （St. George's questionnaire） score |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD