Allergic Rhinitis Due to Grass PollenNCT01953471
Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)
An observational study of Allergic Rhinitis Due to Grass Pollen, run by Hopital Foch at 1 site in France.
Trial summary
Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen
- What is being tested?
- Allergic rhinitis
- How many people
- 959 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Dec 2011
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with allergic rhinitis due to grass pollen
Who may be able to join
- Male or female patients aged between 6 and 65 years.
- Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
- Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
- Patients presented for symptomatic management of allergic rhinitis.
- Patients having Symptoms score ≥ 6.
Who cannot join
- Patients involved in any other clinical/observational study.
- patients unable to fill in the study questionnaires.
- Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
- Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
- Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.
Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Being tested
- Allergic rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergic rhinitisOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis | Not described Receives: Other: Allergic rhinitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.
Measured: 6 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionDec 2011
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 PollenStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DEVILLIER, MD, PhD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953471
- Sponsor's protocol ID
- 2011/09
- Other IDs
- 2011-A00198-33
- Status last verified
- Nov 2016
- First submitted
- 6 Sep 2013
- Last updated
- 3 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.
- ClinicalTrials.gov ID
- NCT01953471
- Acronym / sponsor ID
- 2011/09
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Oct 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.
Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis | – | Other: Allergic rhinitis |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with allergic rhinitis due to grass pollen
Key inclusion criteria (5 listed)
- Male or female patients aged between 6 and 65 years.
- Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
- Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
- Patients presented for symptomatic management of allergic rhinitis.
- Patients having Symptoms score ≥ 6.
Key exclusion criteria (5 listed)
- Patients involved in any other clinical/observational study.
- patients unable to fill in the study questionnaires.
- Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
- Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
- Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
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 |
|---|---|---|
| Allergic rhinitisQuestionnaire | Other | Allergic rhinitis |
Primary outcome
Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.
Time frame: 6 months per patient
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 Nov 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.
Philippe DEVILLIER, MD, PhD principal investigator
Hôpital Foch
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 Pollen, run by Hopital Foch 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 5 inclusion and 5 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 Nov 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 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?
Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire. (time frame: 6 months per patient). 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 Nov 2016.