Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments tulobuterol, tiotropium bromide
Phase phase 4
Sponsor Shanghai Zhongshan Hospital
Start date November 2010
End date November 2011
Trial size 160 participants
Trial identifier NCT01465906, TG1015TLT

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
tulobuterol
patch, 2mg, qN, 3 months
tiotropium bromide
18ug, inhale, qD, 3 months
(Active Comparator)
tiotropium bromide
18ug, inhale, qD, 3 months

Primary Outcomes

Measure
PFT values (pulmonary function test, see description below)
time frame: 3 months
MRC (Medical Research Council) grade
time frame: 3 months

Secondary Outcomes

Measure
SGRQ (St. George's questionnaire) score
time frame: 3 months

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Principal investigator Chunxue Bai, doctor
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Shanghai Zhongshan Hospital.