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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01465906
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: tulobuterol; Drug: Tiotropium Bromide; Drug: tiotropium bromide	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2010
• Anticipated Primary Completion Date: Nov 1, 2011
• Anticipated Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tulobuterol combined with tiotropium bromide	Drug: tulobuterol; patch, 2mg, qN, 3 months; Drug: tiotropium bromide; 18ug, inhale, qD, 3 months
Active Comparator: Tiotropium bromide	Drug: Tiotropium Bromide; 18ug, inhale, qD, 3 months

Outcome Measures

Primary Outcome Measures

1. PFT values (pulmonary function test, see description below) [3 months]

   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.

2. MRC （Medical Research Council） grade [3 months]

Secondary Outcome Measures

1. SGRQ （St. George's questionnaire） score [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

• Principal Investigator: Chunxue Bai, doctor, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chunxue Bai, Director of Respiratory Department , Shanghai Zhongshan Hospita, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT01465906
• Other Study ID Numbers: TG1015TLT
• First Posted: Nov 6, 2011
• Last Update Posted: Nov 9, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Chunxue Bai, Director of Respiratory Department , Shanghai Zhongshan Hospita, Shanghai Zhongshan Hospital: COPD
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bromides; Tiotropium Bromide; Tulobuterol

Study Results

No Results Posted as of Nov 9, 2011