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

Fudan University

Status and phase

Unknown

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Tiotropium Bromide

Drug: tiotropium bromide

Drug: tulobuterol

Study type

Interventional

Funder types

Other

Identifiers

NCT01465906

TG1015TLT

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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