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

NCT03825757 | Completed DMC

• 2 other identifiers: TYH20182032017-001570-42
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

chronic rhinosinusitis with nasal polyps; Acetyl salicylic acid exacerbated respiratory disease

Outcome Measures

Primary Outcomes (1)

• Change in endoscopic Nasal polyp score of both sides of the nasal cavity.

  Change means differences between at time -4 days versus (vs.) at time +11 months post-randomization. Minimum value is 0. Maximum value is 8. A higher score means worse outcome.

  at -4 days vs. at 11 months post-randomization

Secondary Outcomes (2)

• Change in Sinonasal outcome test 22 (SNOT22). Validated nose-specific quality of life questionnaire, 0-110 points.

  at -4 days vs. at 11 months post-randomization

• Change in the Relative forced expiratory volume in 1 second (FEV1%) without bronchodilator.

  at -1 month vs. at 11 months post-randomization

Study Arms (2)

Primaspan tablet 250 mg

EXPERIMENTAL

Primaspan tablet 250 mg (Acetyl salicylic acid): 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day.

Drug: Acetyl Salicylic Acid

Placebo tablet

PLACEBO COMPARATOR

Placebo Oral Tablet: 1/2 tablet once daily during 1 month. 1 tablet once daily during 10 months. If not tolerated the dose 1 tablet x1/day, the patient is allowed to continue with the dose of 1/2 tablet x1/day.

Drug: Placebo Oral Tablet

Interventions

Placebo Oral Tablet DRUG

Placebo Oral Tablet

Also known as: Placebo

Placebo tablet

Acetyl Salicylic Acid DRUG

Primaspan 250 mg tablet Acetyl Salicylic Acid

Also known as: Primaspan 250 mg tablet

Primaspan tablet 250 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• ≥1 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanna Salmi: lead
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

• Toppila-Salmi S, Lyly A, Salmi V, Nuutinen M, Kilpio M, Hanif T, Niemi M, Laulajainen-Hongisto A, Hafren L, Makela M, Kauppi P, Virkkula P, Heleva A. Study protocol for a randomized double-blinded placebo-controlled trial on ASA therapy for patients with chronic rhinosinusitis with nasal polyps, NSAID-exacerbated respiratory disease, and asthma. Front Allergy. 2025 May 20;6:1542481. doi: 10.3389/falgy.2025.1542481. eCollection 2025.

  PMID: 40463360 DERIVED

Related Links

• Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper.
• Aspirin-Exacerbated Respiratory Disease. Publication.

MeSH Terms

Conditions

Disease

Interventions

Tablets

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sanna Toppila-Salmi, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The IMP producer (Galena Pharma Ltd., Kuopio, Finland) has packed the IMP according to study protocol and provides a code of each product. The IMP is used double-blinded in their numbered order. The key of the codes are stored in closed envelopes in Hospital´s locked closet. HYKS-institute performs regular study monitoring
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant Otorhinolaryngologist, PI

Model Details: Randomized double-blinded controlled trial

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: January 31, 2019
• Study Start: January 31, 2019
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)