Trial Outcomes & Findings for Allergic Rhinitis Changes the Sinus Microbiome (NCT NCT01852513)

Results Overview

The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Two weeks following initiation of treatment

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	QNASL Nasal Spray QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL	Placebo Nasal Spray Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray
Overall Study STARTED	20	19
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Allergic Rhinitis Changes the Sinus Microbiome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QNASL Nasal Spray n=20 Participants QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL	Placebo Nasal Spray n=19 Participants Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray	Total n=39 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	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks following initiation of treatment

The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	QNASL Nasal Spray n=20 Participants QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL	Placebo Nasal Spray n=19 Participants Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray
Total Nasal Symptom Score (TNSS)	67.1 score on a scale Standard Deviation 43.2	78.0 score on a scale Standard Deviation 34.3

PRIMARY outcome

Timeframe: Two weeks following initiation of treatment

Population: Those analyzed included all participants with data for this measure at baseline and two weeks.

The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life.

Outcome measures

Outcome measures
Measure	QNASL Nasal Spray n=20 Participants QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL	Placebo Nasal Spray n=18 Participants Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray
Change in RQLQ Score From Baseline to Two Weeks	1.2 Change in scale score Standard Deviation 1.1	1.3 Change in scale score Standard Deviation 1.3

PRIMARY outcome

Timeframe: Two weeks following initiation of treatment

Population: Those analyzed included all participants with data for this measure at baseline and two weeks.

The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment.

Outcome measures

Outcome measures
Measure	QNASL Nasal Spray n=8 Participants QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL	Placebo Nasal Spray n=8 Participants Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray
Change in Percent Eosinophils From Baseline to Two Weeks	1.5 Change in percentage of eosinophils Standard Deviation 3.5	2.1 Change in percentage of eosinophils Standard Deviation 4.8

Adverse Events

QNASL Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Spray

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

Dr. Jayant Pinto, PI

The University of Chicago

Phone: 773-702-6727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place