About this trial
The purpose of this Patient Identification and Characterization (PIC) study is to collect information and perform limited allergy-related procedures to determine if participants can qualify for cat and/or birch tree pollen allergy clinical research studies in the future. The study is also looking at how cat and/or birch tree pollen allergies have affected overall health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults or pediatric participants, ≥5 years of age inclusive (pediatric participants ≥5 years and <18 years and weighing ≥10 kg, to be enrolled where permitted per local regulations/approvals), at the time of signing the informed consent
Participant-reported (and/or caregiver-reported for pediatric participants) and/or documented allergic history as described in the protocol
Positive Skin Prick Test (SPT) at screening: to cat allergen (Part A) and/or to birch allergen (Part B)
Must not currently live with a cat(s) or have lived with a cat(s) in the home for the past 1 year (Part A)
Disqualifiers
Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or participant safety as described in the protocol
History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
Active, chronic infections requiring long-term use of systemic antibiotics, antivirals, or anti-fungal treatments
Trial population
This study will enroll adult and pediatric (aged ≥5 to \<18 years) participants with cat and/or birch allergen induced allergic conjunctivitis with or without allergic rhinitis
Trial design
Cohort
Prospective
Treatments tested in this trial
Noninterventional
Other interventionNo investigational medicinal products will be administered in this study.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants with moderate-to-severe allergic conjunctivitis due to cat allergy who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander
Part A
Proportion of participants with moderate-to-severe allergic conjunctivitis due to birch tree pollen allergy who report "very bothered" or "extremely bothered" by allergic symptoms
Part B
Secondary outcomes
Proportion of participants who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander
Part A
Proportions of participants who report "very bothered" or "extremely bothered" by allergic symptoms due to birch tree pollen
Part B
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: