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

NCT03825757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-27

No results posted yet for this study

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)

Interventions

DRUG

Placebo Oral Tablet

Placebo Oral Tablet

DRUG

Acetyl Salicylic Acid

Primaspan 250 mg tablet Acetyl Salicylic Acid

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Sanna Salmi

    lead OTHER

Principal Investigators

  • Sanna Toppila-Salmi, MD PhD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2023-06-27
Completion
2023-06-27

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825757 on ClinicalTrials.gov