Allergic Rhinitis Due to Grass PollensALTONCT02041624
International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis
An observational study of Allergic Rhinitis Due to Grass Pollens, run by Stallergenes Greer at 1 site in France.
Trial summary
The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollens
- How many people
- 740 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2015
- How long will I take part?
- 5 Years
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with allergic rhino-conjunctivitis are visiting their allergist during grass-pollen season when symptoms are strong. In accordance with the terms of the Marketing Authorization, ORALAIR® treatment has to be set-up "at the right moment" about 4 months before the next grass-pollen season.
Who may be able to join
- Patient of 5 years of age and older at the date of the screening visit
- Patient with proven allergic rhino-conjunctivitis due to grass pollen
- Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT)
- Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season
Who cannot join
- Patient participating in a clinical trial or in an epidemiological study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.
The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.
Read the detailed description
Primary objective:
To describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings.
Secondary objectives:
- To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Keywords
- allergic, rhinitis, conjunctivitis, grass pollen, Allergen ImmunoTherapy (AIT), grass mix
- Medical subject headings
- Rhinitis, Conjunctivitis
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 |
|---|---|---|
| allergic rhino-conjunctivitis | Patient with proven allergic rhino-conjunctivitis due to grass pollen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
The primary objective is to describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass-pollen season in real-life settings.
Measured: patients will be followed for the duration of the treatment, an expected average of 6 months/year
Secondary outcomes (1)
Treatment Effectiveness
To describe the patient's perceived effectiveness of ORALAIR® in allergic rhino-conjunctivitis management in terms of disease intensity, satisfaction and rescue medication
Measured: patients will be followed for the duration of the treatment, an expected average of 6 months/year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Grass PollensStudies 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
- Time perspective
- Prospective
- Enrolment
- 740 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- Alain DIDIER, MD, Principal investigator, Hôpital Larrey, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041624
- Sponsor's protocol ID
- ORA-PES-05-WO
- Acronym
- ALTO
- Status last verified
- Apr 2016
- First submitted
- 14 Jan 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.
- ClinicalTrials.gov ID
- NCT02041624
- Acronym / sponsor ID
- ALTO / ORA-PES-05-WO
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Keywords
- allergic, rhinitis, conjunctivitis, grass pollen, Allergen ImmunoTherapy (AIT), grass mix
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jan 2014 (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 purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.
Detailed description
Primary objective:
To describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings.
Secondary objectives:
- To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication
Study design
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allergic rhino-conjunctivitis | – | –Patient with proven allergic rhino-conjunctivitis due to grass pollen |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with allergic rhino-conjunctivitis are visiting their allergist during grass-pollen season when symptoms are strong. In accordance with the terms of the Marketing Authorization, ORALAIR® treatment has to be set-up "at the right moment" about 4 months before the next grass-pollen season.
Key inclusion criteria (4 listed)
- Patient of 5 years of age and older at the date of the screening visit
- Patient with proven allergic rhino-conjunctivitis due to grass pollen
- Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT)
- Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season
Key exclusion criteria (1 listed)
- Patient participating in a clinical trial or in an epidemiological study
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
Health related quality of life
Time frame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
The primary objective is to describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass-pollen season in real-life settings.
1 secondary outcome
Treatment Effectiveness
Time frame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
Alain DIDIER, MD principal investigator
Hôpital Larrey, Toulouse, 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 Allergic Rhinitis Due to Grass Pollens, run by Stallergenes Greer 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 4 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: stopped early, as of the sponsor's last update on 18 Apr 2016. 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 was stopped early (reason given: Sponsor decision). 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?
Health related quality of life (time frame: patients will be followed for the duration of the treatment, an expected average of 6 months/year). 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 18 Apr 2016.