Allergic RhinoconjunctivitisÍCARANCT02488447
Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis
An observational study of Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 14 sites in Spain.
Trial summary
The purpose of ths study is to evaluate changes in life quality of patients affected by rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an observational, prospective and comparative study before-after immunotherapy treatment with a one year follow-up. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- How many people
- 215 participants
- Where
- 14 sitesSpain
- Study dates
- May 2015to 25 May 2017
- How long will I take part?
- 1 Year
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by Rhinoconjunctivitis with or without asthma
Who may be able to join
- Patients affected by allergic rhinoconjunctivitis sensityzed to one or several aeroallergens.Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013)
- Patients older than 12 years old
- Patients being subsidiaries of receiving allergen immunotherapy treatment
- Patients who obtained a prick test result ≥ 3 mm diameter to any aeroallergen. Positive and negative control of the test should give consistent results.
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to any aeroallergen.
Who cannot join
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator seems relevant so as to interfere with the treatment.
- Patients with a previous history of anaphylaxis
- Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Complejo Hospitalario Universitario La Coruña
A Coruña, Galicia, 15405
Complejp Hospitalario de Cáceres
Cáceres, Extremadura, 10002
Hospital Central de la Cruz Roja
Madrid, 28003
Hospital Fundación Jiménez Díaz
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital del Tajo
Madrid, 28300
Hospital del Norte Infanta Sofía
Madrid, 28702
Hospital Universitario del Henares
Madrid, 28822
Hospital Universitario Fundación Alcorcón
Madrid, 28922
Hospital universitario de Fuenlabrada
Madrid, 28942
Centro Médico Alianza Médica
Valladolid, 47001
Hospital Virgen de la Concha
Zamora, 49022
Hospital Universitario Lozano Blesa
Zaragoza, 50009
Hospital Royo Vilanova
Zaragoza, 50015
About this study
Official title: Prospective Study for Evaluating Life Quality and Its Determinant Factors as Treatment Adherence and Immunotherapy Satisfaction in Patients With Rhinoconjunctivitis With or Without Asthma, Sensitized at Least to One Aeroallergen
The purpose of ths study is to evaluate changes in life quality of patients affected by rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an observational, prospective and comparative study before-after immunotherapy treatment with a one year follow-up.
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergy, Allergic rhinoconjunctivitis, Immunotherapy, Life Quality, Adherence
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality as measured by RQLQ questionaire (≥12years)
Measured: One Year
Secondary outcomes (2)
Adherence as measured by patient diary
Measured: One Year
Treatment Satisfaction as measured by visual analogue scale
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMay 2015
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Fernández Arbeiza, Dr., Principal investigator, Complejo Hospitalario de CáceresEloína González Mancebo, Dra., Principal investigator, Hospital Universitario de FuenlabradaVanesa Sánchez, Dra., Principal investigator, Hospital Universitario del HenaresJose Julio Laguna, Dr., Principal investigator, Hospital Central de la Cruz RojaAlicia Alonso, Dra., Principal investigator, Centro Médico Alianza MédicaAna Mª Callejo, Dra., Principal investigator, Hospital Virgen de la ConchaMª Jesús Trujillo, Dra., Principal investigator, Hospital del TajoRuth Mielgo, Dra., Principal investigator, Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488447
- Sponsor's protocol ID
- BIA-ALE-2014-01
- Other IDs
- ÍCARA
- Acronym
- ÍCARA
- Status last verified
- Oct 2017
- First submitted
- 25 Jun 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Evaluating Life Quality and Its Determinant Factors as Treatment Adherence and Immunotherapy Satisfaction in Patients With Rhinoconjunctivitis With or Without Asthma, Sensitized at Least to One Aeroallergen
- ClinicalTrials.gov ID
- NCT02488447
- Acronym / sponsor ID
- ÍCARA / BIA-ALE-2014-01
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergy, Allergic rhinoconjunctivitis, Immunotherapy, Life Quality, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 2 Jul 2015 (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 ths study is to evaluate changes in life quality of patients affected by rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an observational, prospective and comparative study before-after immunotherapy treatment with a one year follow-up.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by Rhinoconjunctivitis with or without asthma
Key inclusion criteria (5 listed)
- Patients affected by allergic rhinoconjunctivitis sensityzed to one or several aeroallergens.Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013)
- Patients older than 12 years old
- Patients being subsidiaries of receiving allergen immunotherapy treatment
- Patients who obtained a prick test result ≥ 3 mm diameter to any aeroallergen. Positive and negative control of the test should give consistent results.
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to any aeroallergen.
Key exclusion criteria (5 listed)
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator seems relevant so as to interfere with the treatment.
- Patients with a previous history of anaphylaxis
- Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding
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
Life Quality as measured by RQLQ questionaire (≥12years)
Time frame: One Year
2 secondary outcomes
Adherence as measured by patient diary
Time frame: One Year
Treatment Satisfaction as measured by visual analogue scale
Time frame: One Year
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 20 Oct 2017.
Related trials for Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
RecruitingPhase 3
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
Rhinitis, Allergic, Rhinoconjunctivitis
RecruitingPhase 3
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Rhinitis, Allergic, Rhinoconjunctivitis
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.
Francisco Javier Fernández Arbeiza, Dr. principal investigator
Complejo Hospitalario de Cáceres
Eloína González Mancebo, Dra. principal investigator
Hospital Universitario de Fuenlabrada
Vanesa Sánchez, Dra. principal investigator
Hospital Universitario del Henares
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 14 sites in Spain.
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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
Life Quality as measured by RQLQ questionaire (≥12years) (time frame: One 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 20 Oct 2017.