Trial Outcomes & Findings for Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease (NCT NCT01778465)

NCT ID: NCT01778465

Last Updated: 2021-03-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 14 days after commencement
• Results posted on: 2021-03-09

Participant Flow

Participant milestones

Measure	Low Salicylate Diet, Then Normal Diet Participants followed a low salicylate diet for 7 days, then they started a period of 7 days on Normal diet.	Normal Diet, Then Low Salicylate Diet Participants followed a normal diet for 7 days, then they started a period of 7 days on Low Salicylate Diet
First Intervention (7 Days) STARTED	3	4
First Intervention (7 Days) COMPLETED	3	4
First Intervention (7 Days) NOT COMPLETED	0	0
Second Intervention (7 Days) STARTED	3	4
Second Intervention (7 Days) COMPLETED	3	4
Second Intervention (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease

Baseline characteristics by cohort

Measure	All Study Participants n=7 Participants Participants followed a low salicylate diet for one week. Then, participants continued with a normal diet for one week.
Age, Continuous	55 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days after commencement

Outcome measures

Measure	Low Salicylate Diet n=7 Participants Patients followed a low salicylate diet for one week	Normal Diet n=7 Participants Patients followed a Normal diet for one week.
Urinary Levels of Cys-Leukotrienes	874.05 pg/ml Interval 182.6 to 1404.01	771.99 pg/ml Interval 651.23 to 1979.22

PRIMARY outcome

Timeframe: 14 days after commencement

Outcome measures

Measure	Low Salicylate Diet n=7 Participants Patients followed a low salicylate diet for one week	Normal Diet n=7 Participants Patients followed a Normal diet for one week.
Urinary Salicyluric Acid Levels	44.21 ng/ml Interval 20.23 to 54.9	23.82 ng/ml Interval 15.7 to 70.08

PRIMARY outcome

Timeframe: 14 days after enrollment

Outcome measures

Measure	Low Salicylate Diet n=7 Participants Patients followed a low salicylate diet for one week	Normal Diet n=7 Participants Patients followed a Normal diet for one week.
Urinary Salicylic Acid Levels	0.6 ng/ml Interval 0.46 to 3.88	0.92 ng/ml Interval 0.4 to 1.2

PRIMARY outcome

Timeframe: 14 days after commencement

Outcome measures

Measure	Low Salicylate Diet n=7 Participants Patients followed a low salicylate diet for one week	Normal Diet n=7 Participants Patients followed a Normal diet for one week.
Urinary Creatinine Levels	9.9 mmol/L Interval 3.7 to 15.0	15.3 mmol/L Interval 6.2 to 18.8

SECONDARY outcome

Timeframe: 14 days after commencement

The Sino-Nasal Outcome Test (SNOT-22) is a validated 22-item Chronic rhinosinusitis-specific instrument which is scored using a scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be". Higher scores on the SNOT-22 survey items suggest worse patient functioning or symptom severity (total score range: 0-110)

Outcome measures

Measure	Low Salicylate Diet n=7 Participants Patients followed a low salicylate diet for one week	Normal Diet n=7 Participants Patients followed a Normal diet for one week.
Sino-Nasal Outcome Test (SNOT-22)	44 score on a scale Interval 22.0 to 53.0	66 score on a scale Interval 43.0 to 83.0

Adverse Events

Low Salicylate Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Diet

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

Clinical Trials Program Coordinator

Western University

Phone: +15196466100

Email: taciano.rocha@sjhc.london.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place