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

NCT ID: NCT01465906

Last Updated: 2011-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-11-30

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 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

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tulobuterol combined with tiotropium bromide

Group Type: EXPERIMENTAL

tulobuterol

Intervention Type: DRUG

patch, 2mg, qN, 3 months

tiotropium bromide

Intervention Type: DRUG

18ug, inhale, qD, 3 months

Tiotropium bromide

Group Type: ACTIVE_COMPARATOR

Tiotropium Bromide

Intervention Type: DRUG

18ug, inhale, qD, 3 months

Interventions

tulobuterol

patch, 2mg, qN, 3 months

Intervention Type: DRUG

Tiotropium Bromide

18ug, inhale, qD, 3 months

Intervention Type: DRUG

tiotropium bromide

18ug, inhale, qD, 3 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chunxue Bai

Director of Respiratory Department , Shanghai Zhongshan Hospita

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunxue Bai, doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

TG1015TLT

Identifier Type: -

Identifier Source: org_study_id