Status:
UNKNOWN
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01465906
Start Date
November 1 2010
End Date
November 1 2011
Last Update
November 9 2011
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032