Allergic RhinitisNCT02040974
Allergen Immunotherapy in Allergic Patients
An observational study of Allergic Rhinitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic rhinitis patients sensitized to different… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2007to Sep 2014
- How long will I take part?
- 7 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.
Who may be able to join
- allergic rhinitis/asthma
Who cannot join
- pregnancy,
- malignity,
- autoimmunity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Faculty of Medicine
Istanbul, 34093
Mustafa Demirturk, mustafadt@yahoo.com
Mustafa Demirturk
About this study
Official title: Long Term Follow up in Patients Using Immunotherapy: Efficacy and Impact on Quality of Life
Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic rhinitis patients sensitized to different allergens. Also the development of new sensitizations and asthma during the immunotherapy were determined.
Read the detailed description
Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.
- Conditions
- Allergic Rhinitis
- Keywords
- immunotherapy, house dust mites, pollens, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvent of quality of life
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2007
- Primary completionJan 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Demirturk, Istanbul University
- Investigators
- Mustafa Demirturk, Principal investigator, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040974
- Sponsor's protocol ID
- 1978
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up in Patients Using Immunotherapy: Efficacy and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT02040974
- Acronym / sponsor ID
- 1978
- Conditions
- Allergic Rhinitis
- Keywords
- immunotherapy, house dust mites, pollens, allergic rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 20 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.
Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic rhinitis patients sensitized to different allergens. Also the development of new sensitizations and asthma during the immunotherapy were determined.
Detailed description
Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.
Key inclusion criteria (1 listed)
- allergic rhinitis/asthma
Key exclusion criteria (3 listed)
- pregnancy,
- malignity,
- autoimmunity
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
The improvent of quality of life
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Mustafa Demirturk principal investigator
Istanbul Faculty of Medicine
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, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvent of quality of life (time frame: 5 years). 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 20 Jan 2014.