Developing aspirin tolerance in patients who are allergic/sensitized to aspirin

ISRCTN	ISRCTN27096541
DOI	https://doi.org/10.1186/ISRCTN27096541

Submission date: 19/01/2022
Registration date: 25/01/2022
Last edited: 04/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Nonsteroidal exacerbated respiratory disease is a condition where asthma is brought on when taking a type of medication known as a non-steroidal anti-inflammatory, e.g. aspirin.
Aspirin desensitization (AD) is effective in relieving asthma in patients with NERD. So far, only a limited number of studies evaluated the effect of AD prospectively in a controlled manner in NERD. It is also a current approach to recommend endoscopic sinus surgery (ESS) prior to AD. The aim of this study was to prospectively document the clinical effects of AD in patients with NERD for 1 year in the presence of a control group.

Who can participate?
Adult patients with NERD can participate.

What does the study involve?
All participants have ESS before enrolment in the study. Participants of the treatment arm are introduced to aspirin tablets from low to high doses (12.5 -600 mg) for 2-3 days in our inpatient clinic. The patients will be asked to fill in some questionnaires and scoring forms . The asthma control tests, spirometry results, medications and eosinophil counts will be recorded from the patient files. These procedures will repeat at 1st, 6th, and 12th months of the study. The patients will be assessed by an ENT specialist with nasal endoscopy fort he nasal outcomes at the same time points.
The patients in the control arm will have the same schedule above except the aspirin treatment .

What are the benefits and risks of participating?
The possible benefit of participating in the study is the improvement of asthma and nasal outcomes, besides retarding in nasal polyp recurrence.
During the desensitization procedure, allergic reactions can be seen. An allergic reaction during the course is treated by the study investigators. The patients will be followed carefully during the procedure.

Where is the study run from?
Ankara University School of Medicine (Turkey)

When is the study starting and how long is it expected to run for?
August 2008 to August 2009

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Omur Aydin, MD, mdomuraydin@gmail.com

Contact information

Dr Ömür Aydın
Principal Investigator

Ankara University School of Medicine
Chest Disease Department
Allergy and Immunology Division
Dikimevi
Ankara
06260
Türkiye

ORCID ID	0000-0002-3670-1728
Phone	+90 5325881379
Email	omuraydin@ankara.edu.tr

Prof Gulfem Celik
Scientific

Ankara University School of Medicine
Chest Diesease Department
Ankara
06260
Türkiye

Phone	+90 5325881379
Email	gulfemcelik@gmail.com

Study information

Study design	Single center interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	40970 PIS patients.pdf
Scientific title	Aspirin desensitization following endoscopic sinus surgery is effective in patients with NERD: A 1 year prospective and controlled study
Study objectives	Aspirin desensitization is beneficial on clinical outcomes (both asthma and sinonasal outcomes) of patients with nonsteroid exacerbated respiratory disease
Ethics approval(s)	Approved 14/08/2008, Ankara University ethics committee (Ankara University school of medicine, Hacettepe street, Talatpasa square, no: 82, Ankara, Turkey; +90 3125088227; no email provided), ref: 136-3997
Health condition(s) or problem(s) studied	Aspirin treatment in patients with NERD (non-steroid-exacerbated respiratory disease)
Intervention	The patients are non-randomly divided into 2 arms: 1. Active aspirin treatment arm: The patients in this group are desensitized to aspirin in our clinic for 1 week and tolerate a 600 mg/ daily aspirin. 2. Control arm: The patients in this group are also candidate for aspirin desensitization treatment but this procedure could not be performed due to either the patient had a contraindication for aspirin therapy or the patient did not give informed consent. This group is regularly followed up for routine asthma management. All cases have endoscopic sinus surgery (ESS) before enrolment to the study. The asthma and rhinosinusitis outcomes are assessed at baseline and at 1 year.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aspirin
Primary outcome measure	1. Asthma outcomes measured using patient records at 1st, 6th, and 12th months: 1.1 Severe asthma attacks which require at least 3 days of oral corticosteroid treatment 1.2 Hospitalizations due to asthma 1.3 Admission to emergency care and systemic corticosteroid use due to asthma in the last year 1.4. Medication use 1.5 Asthma control measured using the asthma control test 2. Sinonasal outcomes measured using patient records at 1st, 6th, and 12th months: 2.1 Nasal symptom (sneezing, nasal blockage, nasal itching) scores 2.2 Medication use 2.3 Number of sinusitis episodes in the last year 2.4 Number of nasal surgeries due to nasal polyposis in the last year 2.5 Nasal endoscopic findings measured using ENT
Secondary outcome measures	Measured at 1st, 6th, and 12th months: 1. Asthma and rhinitis quality of life questionnaires 2. Pulmonary function tests 3. Eosinophil counts measured using blood test 4. Results of smell tests in the last year measured using olfaction test
Overall study start date	01/08/2008
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20 participants for patient group and 20 for control group. Total participants are 40
Total final enrolment	44
Key inclusion criteria	1. Aged 18 - 65 years 2. Aspirin hypersensitivity
Key exclusion criteria	1. Pregnancy 2. Patients who are failed to be desensitized with aspirin (ie. anaphylaxis) 3. Patients who have a previous history of gastric bleeding
Date of first enrolment	04/08/2008
Date of final enrolment	29/01/2009

Locations

Countries of recruitment

Türkiye

Study participating centre

Ankara University School of Medicine

Ankara University School of Medicine Chest Disease Department
Dikimevi
Ankara
06100
Türkiye

Sponsor information

Ankara University
Hospital/treatment centre

Ankara University School of Medicine
Chest Disease Department, Allergy and Immunology Division
Ankara
06260
Türkiye

Phone	+90 312 2125656
Email	bap@ankara.edu.tr
Website	http://www.medicine.ankara.edu.tr
"ROR"	https://ror.org/01wntqw50

Funders

Funder type

Industry

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	15/02/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet		24/01/2022	No	Yes
Participant information sheet		24/01/2022	No	Yes
Basic results	04/02/2022	04/02/2022	No	No

Additional files

40970 PIS patients.pdf
40970 PIS control group.pdf
ISRCTN27096541_BasicResults_04Feb22.pdf

Editorial Notes

04/02/2022: The basic results of this trial have been uploaded as an additional file.
24/01/2022: Trial's existence confirmed by Ankara University ethics committee.