AsthmaNCT00716677
Dysfunctional Breathing in Difficult Asthma.
An observational study of Asthma, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be used to collect the same data over the same time period in a group of healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Dec 2010
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with physician diagnosis of difficult asthma
Who may be able to join
- Physician diagnosis of difficult asthma
Who cannot join
- Current breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambulatory Respiratory Inductance Plethysmography (RIP). Can it be Used to Help Identify Dysfunctional Breathing in Difficult Asthma?
We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be used to collect the same data over the same time period in a group of healthy controls. This data will then be correlated with the assessment of the supervising consultant as to whether the patient has any element of dysfunctional breathing contributing to their symptoms. It is hoped that the data obtained may in future be used to offer treatment to those patients with dysfunctional breathing.
Read the detailed description
Hypothesis
Dysfunctional breathing patterns are more prevalent in patients with a diagnosis of difficult to treat asthma than healthy volunteers.
Design
This will be an open, prospective study, recruiting sequential patients admitted electively to undergo the difficult asthma protocol (DAP). These patients are generally admitted during a period of stability, but still have significant symptoms despite asthma therapy. Healthy volunteers will be recruited from hospital staff and their family and friends.
We will recruit patients over a 12 to 18 month period and hope to enrol 60 patients. On the final day of their 4 day admission, patients will be asked to wear the life vest from 0800hrs. During the morning they will undergo a 6 minute walk to test to assess their responses during exercise. They will also be reviewed by the supervising consultant to discuss the results of their investigations. While wearing the shirt, the patient will be asked to keep a diary of their activities and symptoms. The Life Shirt can be removed by the patient at the time of discharge.
20 Healthy volunteers will be recruited from the hospital staff. They will be asked to wear the life vest while undertaking their normal daily activities. They will also undertake a 6 minute walk test.
Tidal volume, minute volume and respiratory rate will be recorded at rest and during exertion, aided by the patient diary. Breathing pattern and features of dysfunctional breathing, such as frequent sighs, will also be noted. This will subsequently be correlated with the assessment of the supervising consultant with regard to the presence of dysfunctional breathing.
Data will also be analysed with regard to whether there are any differences between healthy volunteers, patients felt to have asthma, and those felt not to have asthma by their admitting consultant.
- Conditions
- Asthma
- Keywords
- difficult asthma, respiratory inductance plethysmography
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dysfunctional breathing patterns in patients with difficult to control asthma compared with healthy volunteers
Measured: 12/2010
Secondary outcomes (1)
2. Prevalence of dysfunctional breathing patterns in patients with confirmed severe refractory asthma as defined by ATS criteria.
Measured: 12/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Life shirt technology no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Andrew N Menzies-Gow, MB BS PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716677
- Sponsor's protocol ID
- 08/H0708/35
- Status last verified
- Dec 2012
- First submitted
- 15 Jul 2008
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Respiratory Inductance Plethysmography (RIP). Can it be Used to Help Identify Dysfunctional Breathing in Difficult Asthma?
- ClinicalTrials.gov ID
- NCT00716677
- Acronym / sponsor ID
- 08/H0708/35
- Conditions
- Asthma
- Keywords
- difficult asthma, respiratory inductance plethysmography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Life shirt technology no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 16 Jul 2008 (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.
We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be used to collect the same data over the same time period in a group of healthy controls. This data will then be correlated with the assessment of the supervising consultant as to whether the patient has any element of dysfunctional breathing contributing to their symptoms. It is hoped that the data obtained may in future be used to offer treatment to those patients with dysfunctional breathing.
Detailed description
Hypothesis
Dysfunctional breathing patterns are more prevalent in patients with a diagnosis of difficult to treat asthma than healthy volunteers.
Design
This will be an open, prospective study, recruiting sequential patients admitted electively to undergo the difficult asthma protocol (DAP). These patients are generally admitted during a period of stability, but still have significant symptoms despite asthma therapy. Healthy volunteers will be recruited from hospital staff and their family and friends.
We will recruit patients over a 12 to 18 month period and hope to enrol 60 patients. On the final day of their 4 day admission, patients will be asked to wear the life vest from 0800hrs. During the morning they will undergo a 6 minute walk to test to assess their responses during exercise. They will also be reviewed by the supervising consultant to discuss the results of their investigations. While wearing the shirt, the patient will be asked to keep a diary of their activities and symptoms. The Life Shirt can be removed by the patient at the time of discharge.
20 Healthy volunteers will be recruited from the hospital staff. They will be asked to wear the life vest while undertaking their normal daily activities. They will also undertake a 6 minute walk test.
Tidal volume, minute volume and respiratory rate will be recorded at rest and during exertion, aided by the patient diary. Breathing pattern and features of dysfunctional breathing, such as frequent sighs, will also be noted. This will subsequently be correlated with the assessment of the supervising consultant with regard to the presence of dysfunctional breathing.
Data will also be analysed with regard to whether there are any differences between healthy volunteers, patients felt to have asthma, and those felt not to have asthma by their admitting consultant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with physician diagnosis of difficult asthma
Key inclusion criteria (1 listed)
- Physician diagnosis of difficult asthma
Key exclusion criteria (1 listed)
- Current breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dysfunctional breathing patterns in patients with difficult to control asthma compared with healthy volunteers
Time frame: 12/2010
1 secondary outcome
2. Prevalence of dysfunctional breathing patterns in patients with confirmed severe refractory asthma as defined by ATS criteria.
Time frame: 12/2010
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Asthma
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.
Andrew N Menzies-Gow, MB BS PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Jan 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of dysfunctional breathing patterns in patients with difficult to control asthma compared with healthy volunteers (time frame: 12/2010). 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 3 Jan 2013.