Chronic Obstructive Pulmonary DiseasePhase 4NCT01465906
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing tulobuterol and Tiotropium Bromide in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- tulobuterol and Tiotropium Bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- tulobuterol, Tiotropium Bromide
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tulobuterolDrug
patch, 2mg, qN, 3 months
Tiotropium BromideDrug
18ug, inhale, qD, 3 months
tiotropium bromideDrug
18ug, inhale, qD, 3 months
| Study group | Role | What they receive |
|---|---|---|
| tulobuterol combined with tiotropium bromide | Experimental | Not described Receives: Drug: tulobuterol; Drug: tiotropium bromide |
| Tiotropium bromide | Active comparator | Not described Receives: Drug: Tiotropium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFT values (pulmonary function test, see description below)
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.
Measured: 3 months
MRC （Medical Research Council） grade
Measured: 3 months
Secondary outcomes (1)
SGRQ （St. George's questionnaire） score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxue Bai, Shanghai Zhongshan Hospital
- Investigators
- Chunxue Bai, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465906
- Sponsor's protocol ID
- TG1015TLT
- Status last verified
- Nov 2011
- First submitted
- 28 Oct 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01465906
- Acronym / sponsor ID
- TG1015TLT
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tulobuterol combined with tiotropium bromide | Experimental | Drug: tulobuterol, Drug: tiotropium bromide |
| Tiotropium bromide | Active comparator | Drug: Tiotropium Bromide |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tulobuterolpatch, 2mg, qN, 3 months | Drug | tulobuterol combined with tiotropium bromide |
| Tiotropium Bromide18ug, inhale, qD, 3 months | Drug | Tiotropium bromide |
| tiotropium bromide18ug, inhale, qD, 3 months | Drug | tulobuterol combined with tiotropium bromide |
Primary outcome
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
1 secondary outcome
SGRQ （St. George's questionnaire） score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunxue Bai, doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tulobuterol and Tiotropium Bromide in people with Chronic Obstructive Pulmonary Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFT values (pulmonary function test, see description below) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.