Rhinitis, Allergic, SeasonalNCT03014661
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
An observational study of Rhinitis, Allergic, Seasonal, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Quality of life under or after therapy with Pollinex quattro
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Dec 2015
- 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: Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)
Who may be able to join
- Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
- Therapy with Polinex quattro
Who cannot join
- Age <18 years.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Saarland University Hospital. Department of Dermatology
Homburg, Saarland, 66421
About this study
Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro
Read the detailed description
Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Quality of life under or after therapy with Pollinex quattro
- Keywords
- pollinosis, quality of life, specific immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life under or after therapy with Pollinex quattroOther
To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro Receives: Other: Quality of life under or after therapy with Pollinex quattro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire (DLQI)
Measured: during year one, year two, year three of therapy or within 6 months after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Pföhler, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014661
- Sponsor's protocol ID
- PQ-HOM-001
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
- ClinicalTrials.gov ID
- NCT03014661
- Acronym / sponsor ID
- PQ-HOM-001
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- pollinosis, quality of life, specific immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jan 2017 (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.
Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro
Detailed description
Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | – | Other: Quality of life under or after therapy with Pollinex quattroSingle Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)
Key inclusion criteria (2 listed)
- Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
- Therapy with Polinex quattro
Key exclusion criteria (1 listed)
- Age <18 years.
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 |
|---|---|---|
| Quality of life under or after therapy with Pollinex quattroTo measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus. | Other | Single group study |
Primary outcome
Quality of life questionnaire (DLQI)
Time frame: during year one, year two, year three of therapy or within 6 months after completion of therapy
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 9 Jan 2017.
- Individual participant dataSharing planned: No
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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 Rhinitis, Allergic, Seasonal, run by Universität des Saarlandes at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 9 Jan 2017. 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 Germany. 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?
Quality of life questionnaire (DLQI) (time frame: during year one, year two, year three of therapy or within 6 months after completion of therapy). 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 9 Jan 2017.