RhinitisMEDANCT01875276
Evaluating the Need for New Rhinitis Treatment
An observational study of Rhinitis, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions 1. What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy? 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhinitis
- How many people
- 21,203 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Mar 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will have seasonal rhinitis: defined as hay fever/rhinitis diagnosis during the hay fever season period and will be receiving therapy during the hay fever season
Who may be able to join
- The analysis will include patients who, at the index date, receive a therapy prescription for allergic rhinitis and have been diagnosed with a hay fever read code during their time at the practice. The following patients will be included within the study population:
- (i)Patients receiving therapy: defined as those with a prescription for the increase or initiation of hay fever therapy during the hay fever season
- (ii)Hay-fever code recorded ever
Who cannot join
- (i)Patients taking maintenance oral steroids during the baseline period
- (ii)Patients who only received LTRA during the study period and had already been receiving LTRA previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Need for a New Combination Nasal Spray in the Treatment of Seasonal Rhinitis
The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions
- What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy?
- To what extent does initial therapy not meet clinical need (as measured by need for additional medical intervention in terms of consultations and changes in therapy)?
- Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?
Read the detailed description
Allergic rhinitis is a chronic respiratory disease with a major impact on quality of life. In a study looking at the burden of allergic rhinitis amongst UK patients 75% reported some impact of their allergic rhinitis symptoms on health-related quality of life. Allergic rhinitis currently affects 10-30% of the world population with prevalence and impact continuing to increase. This leads to substantial economic costs both of prescription medication and time taken off work by both patients and carers due to the disease. In view of this, there may be a substantial need for improved therapy or management to ensure that patients with allergic rhinitis can carry out a normal lifestyle.
The proposed study will evaluate the unmet therapy need in seasonal rhinitis by examining the current medication requirements of patients who suffer from seasonal grass-pollen hay fever and determining whether current therapies are sufficient for managing rhinitis.
This study aims to evaluate the unmet therapy need in seasonal rhinitis by -
- Examining and describing current medication requirements
- Quantifying the extent of co-prescribing of multiple agents
- Comparing the effectiveness of current prescription drugs for managing and controlling patient's seasonal rhinitis and using changes in treatment during the hay fever season to determine the effectiveness of current therapy options. for managing and controlling seasonal rhinitis in primary care patients who suffer from seasonal grass-pollen hay fever.
- Conditions
- Rhinitis
- Keywords
- Rhinitis, Antihistamine, Nasal Steroid Therapy
- Medical subject headings
- Rhinitis
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 |
|---|---|---|
| Persistent Patients | Defined as those with ≥1 treatment for allergic rhinitis in the six months preceding the IPD (defined as the first script of the hay fever season - May to August) | |
| Seasonal Rhinitis | No treatment for allergic rhinitis in the six months preceding the IPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-prescribing
The proportion of patients managed at the index prescription date with more than one class of therapy
Measured: 31.11.12
Treatment Outcomes
For those patients who receive a prescription for a diagnosis of seasonal rhinitis/ hay fever. The following outcomes will be measured -
- Patients who remain on the same therapy
- Patients who change therapy within same therapy group
- Patients who add additional therapy from another therapy group
Measured: 10.12.12
Number of Consultations
Defined as a consultation where an allergic rhinitis read code or hay fever code is recorded during the hay fever season.
Measured: 10.12.12
Asthma Patients - Exacerbations: Clinical
where exacerbation is defined as an occurrence of the following:
a)Lower respiratory related : Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance;
- GP consultations for lower respiratory related tract infections;
- Acute use of oral steroids .
Measured: 10.12.12
Asthma Patients - Exacerbations: Severe
b)Asthma related -
Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance; GP consultations for asthma related tract infections; Acute use of oral steroids
Measured: 10.12.12
Costing Analysis
Descriptive analysis of costs at the first prescription and final prescription of the season. Comparing those who remain on same therapy and those who add therapy during the season.
Measured: 15.01.13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Meda Pharmaceuticals
- Responsible party
- Principal investigator, David Price, Prof., MD, Research in Real-Life Ltd
- Investigators
- David Price, Prof, MD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875276
- Sponsor's protocol ID
- R04412
- Acronym
- MEDA
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
PubMed 15080802Van Cauwenberge P, Van Hoecke H, Kardos P, Price D, Waserman S. The current burden of allergic rhinitis amongst primary care practitioners and its impact on patient management. Prim Care Respir J. 2009 Mar;18(1):27-33. doi: 10.3132/pcrj.2008.00042.
PubMed 18622524Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011 Feb;106(2 Suppl):S12-6. doi: 10.1016/j.anai.2010.10.014.
PubMed 21277528
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Need for a New Combination Nasal Spray in the Treatment of Seasonal Rhinitis
- ClinicalTrials.gov ID
- NCT01875276
- Acronym / sponsor ID
- MEDA / R04412
- Conditions
- Rhinitis
- Keywords
- Rhinitis, Antihistamine, Nasal Steroid Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,203 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Meda Pharmaceuticals
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jun 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.
The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions
- What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy?
- To what extent does initial therapy not meet clinical need (as measured by need for additional medical intervention in terms of consultations and changes in therapy)?
- Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?
Detailed description
Allergic rhinitis is a chronic respiratory disease with a major impact on quality of life. In a study looking at the burden of allergic rhinitis amongst UK patients 75% reported some impact of their allergic rhinitis symptoms on health-related quality of life. Allergic rhinitis currently affects 10-30% of the world population with prevalence and impact continuing to increase. This leads to substantial economic costs both of prescription medication and time taken off work by both patients and carers due to the disease. In view of this, there may be a substantial need for improved therapy or management to ensure that patients with allergic rhinitis can carry out a normal lifestyle.
The proposed study will evaluate the unmet therapy need in seasonal rhinitis by examining the current medication requirements of patients who suffer from seasonal grass-pollen hay fever and determining whether current therapies are sufficient for managing rhinitis.
This study aims to evaluate the unmet therapy need in seasonal rhinitis by -
- Examining and describing current medication requirements
- Quantifying the extent of co-prescribing of multiple agents
- Comparing the effectiveness of current prescription drugs for managing and controlling patient's seasonal rhinitis and using changes in treatment during the hay fever season to determine the effectiveness of current therapy options. for managing and controlling seasonal rhinitis in primary care patients who suffer from seasonal grass-pollen hay fever.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persistent Patients | – | –Defined as those with ≥1 treatment for allergic rhinitis in the six months preceding the IPD (defined as the first script of the hay fever season - May to August) |
| Seasonal Rhinitis | – | –No treatment for allergic rhinitis in the six months preceding the IPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will have seasonal rhinitis: defined as hay fever/rhinitis diagnosis during the hay fever season period and will be receiving therapy during the hay fever season
Key inclusion criteria (3 listed)
- The analysis will include patients who, at the index date, receive a therapy prescription for allergic rhinitis and have been diagnosed with a hay fever read code during their time at the practice. The following patients will be included within the study population:
- (i)Patients receiving therapy: defined as those with a prescription for the increase or initiation of hay fever therapy during the hay fever season
- (ii)Hay-fever code recorded ever
Key exclusion criteria (2 listed)
- (i)Patients taking maintenance oral steroids during the baseline period
- (ii)Patients who only received LTRA during the study period and had already been receiving LTRA previously
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
Co-prescribing
Time frame: 31.11.12
The proportion of patients managed at the index prescription date with more than one class of therapy
Treatment Outcomes
Time frame: 10.12.12
For those patients who receive a prescription for a diagnosis of seasonal rhinitis/ hay fever. The following outcomes will be measured - * Patients who remain on the same therapy * Patients who change therapy within same therapy group * Patients who add additional therapy from another therapy group
Number of Consultations
Time frame: 10.12.12
Defined as a consultation where an allergic rhinitis read code or hay fever code is recorded during the hay fever season.
Asthma Patients - Exacerbations: Clinical
Time frame: 10.12.12
where exacerbation is defined as an occurrence of the following: a)Lower respiratory related : Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance; * GP consultations for lower respiratory related tract infections; * Acute use of oral steroids .
Asthma Patients - Exacerbations: Severe
Time frame: 10.12.12
b)Asthma related - Hospital attendance/admission OR A \& E attendance; OR Out-of-hours attendance; GP consultations for asthma related tract infections; Acute use of oral steroids
Costing Analysis
Time frame: 15.01.13
Descriptive analysis of costs at the first prescription and final prescription of the season. Comparing those who remain on same therapy and those who add therapy during the season.
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 11 Jun 2013.
- Background: PubMed 15080802Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
- Results publication: PubMed 18622524Van Cauwenberge P, Van Hoecke H, Kardos P, Price D, Waserman S. The current burden of allergic rhinitis amongst primary care practitioners and its impact on patient management. Prim Care Respir J. 2009 Mar;18(1):27-33. doi: 10.3132/pcrj.2008.00042.
- Results publication: PubMed 21277528Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011 Feb;106(2 Suppl):S12-6. doi: 10.1016/j.anai.2010.10.014.
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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.
David Price, Prof, MD principal investigator
University of Aberdeen
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 Rhinitis, run by Research in Real-Life Ltd 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 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 11 Jun 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 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?
Co-prescribing (time frame: 31.11.12). The study lists 6 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 NCT01875276, which also lists 3 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 11 Jun 2013.