COPDNCT01891942
Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
A study testing twitch by magstim in people with COPD and Healthy, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- What is being tested?
- twitch by magstim
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2013
- Phase
- Interventional
- 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 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD
- Stable with no episodes of exacerbation within the previous 2 months
- Do not currently being treated with oral corticosteroids
Who cannot join
- Not stable within the previous 2 months.
- Patients with COPD were currently being treated with oral corticosteroids
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute Respiratory Disease
Guangzhou, Guangdong, 510120
About this study
The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients.
- Being tested
- twitch by magstim
- Keywords
- Normal, subjects
- 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.
twitch by magstimProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | All of the COPD patients included in this study were stable with no episodes of exacerbation within the previous 2 months. Patients with COPD were not currently being treated with oral corticosteroids. Receives: Procedure: twitch by magstim |
| normal subjects | Experimental | Fifteen healthy men with normal lung function Receives: Procedure: twitch by magstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twitch mouth pressure
Measured: 2 weeks
Secondary outcomes (1)
Twitch oesophageal pressure
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DM Hua, Guangzhou Institute of Respiratory Disease
- Investigators
- Rong-chang Chen, Master, Study chair, Guangzhou Instiute of Respiratory DiseaseDong-ming Hua, Master, Principal investigator, Guangzhou Institue of Respiratory DiseaseNan-shan Zhong, Bachelor, Study chair, Guangzhou Institue of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891942
- Sponsor's protocol ID
- GIRD-566
- Other IDs
- GIRD-566
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walker DJ, Ertl T, Walterspacher S, Schlager D, Roecker K, Windisch W, Kabitz HJ. Respiratory muscle function during a six-week period of normocapnic hyperpnoea training. Respir Physiol Neurobiol. 2013 Aug 15;188(2):208-13. doi: 10.1016/j.resp.2013.05.005. Epub 2013 May 17.
PubMed 23689008Hua DM, Liang YH, Xie YK, Liu Q, Zheng ZG, Chen RC, Zhong NS. Use of twitch mouth pressure to assess diaphragm strength in patients with chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2013 Jul 1;187(3):211-6. doi: 10.1016/j.resp.2013.04.012. Epub 2013 Apr 15.
PubMed 23597835
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
- ClinicalTrials.gov ID
- NCT01891942
- Acronym / sponsor ID
- GIRD-566
- Keywords
- Normal, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Jul 2013 (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.
The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Procedure: twitch by magstimAll of the COPD patients included in this study were stable with no episodes of exacerbation within the previous 2 months. Patients with COPD were not currently being treated with oral corticosteroids. |
| normal subjects | Experimental | Procedure: twitch by magstimFifteen healthy men with normal lung function |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of COPD
- Stable with no episodes of exacerbation within the previous 2 months
- Do not currently being treated with oral corticosteroids
Key exclusion criteria (2 listed)
- Not stable within the previous 2 months.
- Patients with COPD were currently being treated with oral corticosteroids
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 |
|---|---|---|
| twitch by magstim | Procedure or surgery | COPD patients, normal subjects |
Primary outcome
Twitch mouth pressure
Time frame: 2 weeks
1 secondary outcome
Twitch oesophageal pressure
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Results publication: PubMed 23689008Walker DJ, Ertl T, Walterspacher S, Schlager D, Roecker K, Windisch W, Kabitz HJ. Respiratory muscle function during a six-week period of normocapnic hyperpnoea training. Respir Physiol Neurobiol. 2013 Aug 15;188(2):208-13. doi: 10.1016/j.resp.2013.05.005. Epub 2013 May 17.
- Results publication: PubMed 23597835Hua DM, Liang YH, Xie YK, Liu Q, Zheng ZG, Chen RC, Zhong NS. Use of twitch mouth pressure to assess diaphragm strength in patients with chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2013 Jul 1;187(3):211-6. doi: 10.1016/j.resp.2013.04.012. Epub 2013 Apr 15.
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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.
Rong-chang Chen, Master study chair
Guangzhou Instiute of Respiratory Disease
Dong-ming Hua, Master principal investigator
Guangzhou Institue of Respiratory Disease
Nan-shan Zhong, Bachelor study chair
Guangzhou Institue of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing twitch by magstim in people with COPD and Healthy, run by Guangzhou Institute of Respiratory Disease 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jul 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Twitch mouth pressure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891942, which also lists 2 linked publications.
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 3 Jul 2013.