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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shanghai Zhongshan Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium
Tulobuterol
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on October 19, 2014