Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2027
  • participants needed
    150
  • sponsor
    Sanna Salmi
Updated on 7 April 2021

Summary

The study is performed as a randomized double-blinded prospective controlled trial. A total of 72 adult Acetyl salicylic acid (ASA) -exacerbated respiratory disease (AERD) -patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) will be recruited. Those negative to ASA-challenge test will not enter the Clinical Trial . All patients entering the Clinical Trial, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. The patients are recruited at the Helsinki University Hospital (HUH). The study will be monitored by a professional monitor. Electronic CRF and paper/electronic patient questionnaires provided by HUS will be used (eCRF and patient questionnairea, Granitics).

Description

Randomization and the treatment arms I-II: The patients are randomized to two treatment arms I) ASA- desensitization po tablet daily for 11 months (n=36) II) Placebo po tablet daily for 11 months (n=18).

ASA challenge and desensitization (Primaspan) /Placebo: is conducted according to modified international protocol. FEV1 should be at least 1.5 L and > 60% of predicted before challenge or desensitization. On the first day every patient will receive 25 mg + 25 mg ASA at a hospital setting. On the second day every patient will receive 50 mg + 25 mg ASA at a hospital setting. On the third day every patient will receive 75 mg + 25 mg ASA at a hospital setting. On the fourth day every patient will receive 100 mg + 25 mg ASA at a hospital setting.

During the ASA challenge, patient who is ASA-challenge positive is then randomized and starts the trial so that he/she uses blinded tablet of 250 mg ASA or tablet of placebo daily at home for the next 1 month. After this period of 1 month, the dosing is increased at hospital setting, so that the patient receives blindly 250 mg ASA 1/2 tablet + 1/2 tablet or placebo 1/2 tablet + 1/2 tablet. Thereafter he/she will continue using blindly 250 mg ASA 1 tablet or placebo 1 tablet daily at home for the next 10 months. If the patient does not tolerate the up-dosing of ASA/placebo, he/she will continue using blindly tablet of 250 mg ASA/placebo daily at home for the next 10 months. The total duration of the ASA/placebo treatment is 11 months. We additionally take nasal, blood and urine samples during the trial.

Follow-ups. The symptom questionnaire and interview of side-effects are performed during each visit. Lung function (eNO, nNO, PEF, spirometry) is monitored and the patient will visit doctor and/or nurse at 1, 5, 11, and 12 months post-starting with the treatment. Samples are taken during recruitment visit, before and after ASA-challenge and at 5, 11 and 12 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment.

Primary end point is change in nasal endoscopic nasal polyp score at -4 days vs. +11 months post-randomization. Secondary end point is change in Sinonasal Outcome Test -22 (SNOT-22) score at -4 days vs. +11 months post-randomization, and change in relative Forced expiratory volume in 1 second (FEV1 %) without bronchodilator at -1 month vs. +11 months post-randomization.

Safety (complications, adverse effects), costs and loss of productivity between study arms will be compared.

Trial medication will be discontinued, if surgery is needed before the end of follow-up.

Details
Condition Chronic Sinusitis, Chronic Rhinosinusitis
Treatment Placebo Oral Tablet, Acetyl Salicylic acid
Clinical Study IdentifierNCT03825757
SponsorSanna Salmi
Last Modified on7 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ALL these need to be positive
Endoscopic nasal polyp score 4
SNOT-22 30
Sinus Computed tomography Lund-Mackay score 14. The new sinus CT scans are needed if the previous sinus CT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis)
previous partial/total ethmoidectomy surgery
In addition, patient should have a history of at least one of the following
>1 oral corticosteroids during the past two years >3 antibiotic courses during
the past two years. In patients with contraindication/adverse effects in using
oral steroids additional criteria are not required

Exclusion Criteria

complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
bleeding diathesis
pregnancy/ breastfeeding
cystic fibrosis
primary ciliary dyskinesia (PCD)
sarcoidosis
granulomatosis with polyangitis (GPA)
eosinophilic granulomatosis with polyangitis (EGPA)
immunosuppression (diagnosed Spesific antibody deficiency (SAD), CVI, HIV
use of biologicals/immunosuppressive medication
immunotherapy
Daily use of systemic corticosteroids (Prednisolon 10mg or equivalent) -communication problems (f.e. neurological/psychiatric disease, language skills) -unlikely to comply
other severe disease
uncontrolled asthma
ASA-challenge negative
gastric ulcer
anticoagulant treatment
SSRI-depression medication
beta-blocker
severe chronic urticaria
ASA anaphylaxis
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