AsthmaLIAISONNCT01567280
International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 8,111 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic patients (in treatment with the same antiasthmatic therapy for at least 4 weeks) visiting the centre.
Who may be able to join
- Written informed consent obtained.
- Male or female adult (at least 18 years of age) patients with asthma diagnosed (according to GINA guidelines and confirmed by a chest physician) for at least 6 months.
- Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment.
Who cannot join
- Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study.
- Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time.
Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.
- Conditions
- Asthma
- 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 |
|---|---|---|
| Controlled patients | Asthmatic patients with controlled asthma (according to ACQ score) | |
| Partly controlled/Uncontrolled patients | Patients with partly controlled or uncontrolled asthma (according to ACQ score) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire score
Measured: 3 months
Mini Asthma Quality of Life 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 posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionOct 2014
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 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
- 8,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567280
- Sponsor's protocol ID
- DFIDM-1101
- Acronym
- LIAISON
- Status last verified
- Jul 2020
- First submitted
- 29 Mar 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Braido F, Brusselle G, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON study group. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients--the LIAISON study protocol. BMC Pulm Med. 2013 Mar 25;13:18. doi: 10.1186/1471-2466-13-18.
PubMed 23530817Braido F, Brusselle G, Guastalla D, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON Study Group. Determinants and impact of suboptimal asthma control in Europe: The INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study. Respir Res. 2016 May 14;17(1):51. doi: 10.1186/s12931-016-0374-z.
PubMed 27179604
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)
- ClinicalTrials.gov ID
- NCT01567280
- Acronym / sponsor ID
- LIAISON / DFIDM-1101
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,111 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Mar 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 study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time.
Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled patients | – | –Asthmatic patients with controlled asthma (according to ACQ score) |
| Partly controlled/Uncontrolled patients | – | –Patients with partly controlled or uncontrolled asthma (according to ACQ score) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic patients (in treatment with the same antiasthmatic therapy for at least 4 weeks) visiting the centre.
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
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
Asthma Control Questionnaire score
Time frame: 3 months
Mini Asthma Quality of Life Questionnaire score
Time frame: 3 months
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 31 Jul 2020.
- Background: PubMed 23530817Braido F, Brusselle G, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON study group. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients--the LIAISON study protocol. BMC Pulm Med. 2013 Mar 25;13:18. doi: 10.1186/1471-2466-13-18.
- Results publication: PubMed 27179604Braido F, Brusselle G, Guastalla D, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON Study Group. Determinants and impact of suboptimal asthma control in Europe: The INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study. Respir Res. 2016 May 14;17(1):51. doi: 10.1186/s12931-016-0374-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Italy.
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 31 Jul 2020. 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 Italy. 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?
Asthma Control Questionnaire score (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?
On the ClinicalTrials.gov record for NCT01567280, 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 31 Jul 2020.