Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects

Allergic Rhinitis Clinical Trial

— NEC  

Official title:

A Single-Group Study Evaluating Reproducibility of Rhinitis Symptoms Induced by Cat Allergen (Fel d1) Exposure in the Red Maple Trials Natural Exposure Chamber (NEC) ™ in Subjects With Cat Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414801
• Other study ID #: RMT005
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2018
• Source: Red Maple Trials Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.

Description:

To validate the Red Maple Trials Natural Exposure Chamber for cat exposure studies in non-asthmatic subjects with perennial allergic rhinitis and allergy to cat dander by examining the reproducibility of the response on two allergen challenge days and comparing the response of allergic to non-allergic subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 30, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for Allergic Subjects:

• Male and female adults, 18 years to 65 years of age

• Willing and able to give informed consent for participation in the study.

• Otherwise healthy with a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years

• With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal =3 mm larger than the negative control performed at the screening visit or within 6 months of the screening visit provided that complete documentation (specific allergen used for the SPT and the size of the reaction) is available

• Having sufficient rhinoconjunctivitis symptoms (TRCSS score =5) during the first cat challenge

• If subjects are taking medications (other than allergy medications), the dosing must be stable for at least 4 weeks prior to study entry

• With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study

• Able (in the investigators opinion) and willing to comply with all study requirements

Exclusion Criteria for Allergic Subjects:

• Subjects with a cat at home or who are regularly exposed to cats during the study period

• Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only

• Subjects with a history of anaphylactic reactions defined as previous or current presentation with two or more of the following:

• Involvement of the skin or mucosa

• respiratory difficulties

• low blood pressure

• gastrointestinal symptoms

• Subjects who have undergone allergen desensitization for cat allergy within the last 2 years

• Subjects with structural nasal defects or nasal polyps

• Subjects with a positive skin-prick test reaction to house dust mite

• Subjects having an infection of the upper airways within 2 weeks prior to the screening visit.

• Subjects who develop an upper respiratory tract infection during the study will be discontinued

• Subjects who have received treatment with Xolair or immunosuppressants during the 4 months prior to the screening visit

• Subjects who wear contact lenses will not be permitted to wear them during the challenge sessions

• Female subjects who are pregnant or lactating at screening or who are planning pregnancy during the course of the study

• Subjects with significant renal or hepatic impairment at screening

• Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study

• Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study

• Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit

• Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)

• Subjects with a history of alcohol or drug abuse within the previous 5 years

• Subjects with known HIV or hepatitis B or C positivity

• Subjects who for any reason would be unlikely to comply with the study requirements

Inclusion Criteria for non allergic subjects:

• Healthy male and female adults, 18 years to 65 years of age

• Willing and able to give informed consent for participation in the study.

• With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study

• Able (in the investigators opinion) and willing to comply with all study requirements

Exclusion Criteria for non allergic subjects:

• With a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years

• With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal =3 mm larger than the negative control performed at the screening visit

• Subjects with a cat at home or who are regularly exposed to cats during the study period

• Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only

• Subjects with a history of anaphylactic reactions defined as previous or current presentation with two or more of the following:

• Involvement of the skin or mucosa

• respiratory difficulties

• low blood pressure

• gastrointestinal symptoms

• Subjects with structural nasal defects or nasal polyps

• Subjects with a positive skin-prick test reaction to house dust mite

• Subjects having an infection of the upper airways within 2 weeks prior to the screening visit.

• Subjects who develop an upper respiratory tract infection during the study will be discontinued

• Subjects who have received treatment with Xolair or immunosuppressants during the 4 months prior to the screening visit

• Subjects who wear contact lenses will not be permitted to wear them during the challenge sessions

• Female subjects who are pregnant or lactating at screening or who are planning pregnancy during the course of the study

• Subjects with significant renal or hepatic impairment at screening

• Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study

• Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study

• Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit

• Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)

• Subjects with a history of alcohol or drug abuse within the previous 5 years

• Subjects with known HIV or hepatitis B or C positivity

• Subjects who for any reason would be unlikely to comply with the study requirements

Related Conditions & MeSH terms

• Allergic Rhinitis
• Exposure
• Rhinitis
• Rhinitis, Allergic
• Rhinoconjunctivitis

Intervention

Other:
• Allergen Exposure
Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.

Locations

Country	Name	City	State
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Red Maple Trials Inc.	Ottawa Allergy Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Total Nasal Symptom Score (TNSS) change from baseline to the end of the challenge between the two challenge days (Visits 2 and 3) in the cat-allergic subjects	Runny nose, sneezing, blocked nose, itchy nose	15 weeks
Secondary	TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects		15 weeks
Secondary	Difference in exposure time between the two exposure days for all subjects		15 weeks
Secondary	Comparison of the exposure times of allergic compared to non-allergic subjects		15 weeks
Secondary	Comparison of TNSS at individual time points on the two exposure days	Runny nose, sneezing, blocked nose, itchy nose	15 weeks
Secondary	Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days	Wheezing, shortness of breath, coughing	15 weeks
Secondary	Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days	Sum of TNSS and TOSS	15 weeks
Secondary	Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days	Itchy eyes and watery eyes	15 weeks
Secondary	Comparison of Fel d1 levels during the exposures		15 weeks