Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Chunxue Bai, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01465906
First received: October 28, 2011
Last updated: November 8, 2011
Last verified: November 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: tulobuterol Drug: Tiotropium Bromide Drug: tiotropium bromide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Shanghai Zhongshan Hospital:
Primary Outcome Measures:
- PFT values (pulmonary function test, see description below) [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- MRC （Medical Research Council） grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SGRQ （St. George's questionnaire） score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465906
Locations
| China, Shanghai | |
| Zhongshan Hospital, Fudan University | |
| Shanghai, Shanghai, China, 200032 | |
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
| Principal Investigator: | Chunxue Bai, doctor | Fudan University |
More Information
No publications provided
| Responsible Party: | Chunxue Bai, Director of Respiratory Department , Shanghai Zhongshan Hospita, Shanghai Zhongshan Hospital |
| ClinicalTrials.gov Identifier: | NCT01465906 History of Changes |
| Other Study ID Numbers: | TG1015TLT |
| Study First Received: | October 28, 2011 |
| Last Updated: | November 8, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai Zhongshan Hospital:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Tulobuterol Tiotropium Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013