AsthmaDist'air2NCT01573364
Prevalence and Reversibility of Lung Hyperinflation in Asthma
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in France.
Trial summary
The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jan 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults
Who may be able to join
- Patient with a diagnosis of uncontrolled persistent asthma (ACT </= 19) or with an MRC score of dyspnea >/= 1
- Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test
Who cannot join
- Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea
The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.
Read the detailed description
The other objectives are :
- the evaluation of the hyperinflation defined by an increase of the residual volume (RV),
- the observation of the relationship between the hyperinflation and the asthma characteristics,
- the study of the improvement of the functional parameters after a reversibility test
- the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea
- Conditions
- Asthma
- Keywords
- Distal Airways, Hyperinflation, Reversibility
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Capucine de Meynard, MD, Study director, Chiesi S.A.Daniel Dusser, MD, Prof, Study chair, Hopital Cochin Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573364
- Sponsor's protocol ID
- EQFST5213
- Acronym
- Dist'air2
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2012
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.
PubMed 26466328
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea
- ClinicalTrials.gov ID
- NCT01573364
- Acronym / sponsor ID
- Dist'air2 / EQFST5213
- Conditions
- Asthma
- Keywords
- Distal Airways, Hyperinflation, Reversibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Apr 2012 (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 aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.
Detailed description
The other objectives are :
- the evaluation of the hyperinflation defined by an increase of the residual volume (RV),
- the observation of the relationship between the hyperinflation and the asthma characteristics,
- the study of the improvement of the functional parameters after a reversibility test
- the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (2 listed)
- Patient with a diagnosis of uncontrolled persistent asthma (ACT </= 19) or with an MRC score of dyspnea >/= 1
- Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test
Key exclusion criteria (1 listed)
- Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months
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
Not reported in the source record.
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 9 Apr 2012.
- Derived from this study: PubMed 26466328Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.
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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.
Capucine de Meynard, MD study director
Chiesi S.A.
Daniel Dusser, MD, Prof study chair
Hopital Cochin Paris France
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 Chiesi Farmaceutici S.p.A. at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 9 Apr 2012. 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 France. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573364, which also lists 1 linked publication.
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 Apr 2012.