Trial Outcomes & Findings for Nasal Allergen Challenge in Rhinitic Subjects (NCT NCT01286129)

Results Overview

Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

At 7 hours post first and last challenge compared to baseline

Results posted on

2019-02-01

Participant Flow

Subjects were recruited from advertisement between November 2005 and october 2008

After enrollment, there was a one to 7 days run-in period. Subjects that could not produce a quality sputum sample were excluded from the trial.

Participant milestones

Participant milestones
Measure	Allergic Asthmatic Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Allergic Rhinitic Without Asthma Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Overall Study STARTED	27	18
Overall Study COMPLETED	19	13
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Allergic Asthmatic Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Allergic Rhinitic Without Asthma Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Overall Study Withdrawal by Subject	4	1
Overall Study Could not comply with study requirements	4	4

Baseline Characteristics

Nasal Allergen Challenge in Rhinitic Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allergic Asthmatic n=27 Participants Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Allergic Rhinitic Without Asthma n=18 Participants Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24 years STANDARD_DEVIATION 4 • n=5 Participants	24 years STANDARD_DEVIATION 7 • n=7 Participants	24 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Canada	27 participants n=5 Participants	18 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: At 7 hours post first and last challenge compared to baseline

Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.

Outcome measures

Outcome measures
Measure	Allergic Asthmatic n=19 Participants Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Allergic Rhinitic Without Asthma n=13 Participants Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Change in Sputum Eosinophils Following Allergen Challenge Baseline percentage eosinophils	5.6 percentage of sputum eosinophils Standard Error 1.8	2.0 percentage of sputum eosinophils Standard Error 1.3
Change in Sputum Eosinophils Following Allergen Challenge 7h post first challenge percentage eosinophils	6.0 percentage of sputum eosinophils Standard Error 1.7	1.3 percentage of sputum eosinophils Standard Error 1.5
Change in Sputum Eosinophils Following Allergen Challenge 7h post last challenge percentage eosinophils	4.1 percentage of sputum eosinophils Standard Error 1.4	1.6 percentage of sputum eosinophils Standard Error 1.0

SECONDARY outcome

Timeframe: At 7 hours post first and last challenge compared to baseline

Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge

Outcome measures

Outcome measures
Measure	Allergic Asthmatic n=19 Participants Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Allergic Rhinitic Without Asthma n=13 Participants Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Change in Nasal Lavage Eosinophils After Allergen Challenge Baseline percentage eosinophils	2.1 percentage of nasal lavage eosinophils Standard Error 0.6	1.3 percentage of nasal lavage eosinophils Standard Error 0.9
Change in Nasal Lavage Eosinophils After Allergen Challenge 7h post first challenge percentage eosinophils	7.5 percentage of nasal lavage eosinophils Standard Error 4.3	3.0 percentage of nasal lavage eosinophils Standard Error 1.3
Change in Nasal Lavage Eosinophils After Allergen Challenge 7h post last challenge percentage eosinophils	15.7 percentage of nasal lavage eosinophils Standard Error 5.4	15.5 percentage of nasal lavage eosinophils Standard Error 9.6

Adverse Events

Allergic Asthmatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Allergic Rhinitic Without Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Louis-Philippe Boulet, principal investigator

IUCPQ

Phone: 418-656-4747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place