Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465906
Recruitment Status : Unknown
Verified November 2011 by Chunxue Bai, Shanghai Zhongshan Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Chunxue Bai, Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date  ICMJE October 28, 2011
First Posted Date  ICMJE November 6, 2011
Last Update Posted Date November 9, 2011
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
  • PFT values (pulmonary function test, see description below) [ Time Frame: 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.
  • MRC (Medical Research Council) grade [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
  • PFT values (see description below) [ Time Frame: 3 months ]
    IC 、PEF、FVC、FEV1、%FEV1、RV、TLC、RV/TLC%, etc.
  • MRC grade [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
SGRQ (St. George's questionnaire) score [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
SGRQ score [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Not Provided
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: tulobuterol
    patch, 2mg, qN, 3 months
  • Drug: Tiotropium Bromide
    18ug, inhale, qD, 3 months
  • Drug: tiotropium bromide
    18ug, inhale, qD, 3 months
Study Arms  ICMJE
  • Experimental: tulobuterol combined with tiotropium bromide
    Interventions:
    • Drug: tulobuterol
    • Drug: tiotropium bromide
  • Active Comparator: Tiotropium bromide
    Intervention: Drug: Tiotropium Bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2011
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01465906
Other Study ID Numbers  ICMJE TG1015TLT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chunxue Bai, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chunxue Bai, doctor Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP