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

Sponsor
Sanna Salmi (Other)
Overall Status
Recruiting
CT.gov ID
NCT03825757
Collaborator
University of Helsinki (Other)
150
Enrollment
1
Location
2
Arms
97.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo Oral Tablet
  • Drug: Acetyl Salicylic Acid
 N/A

Detailed Description

Randomization and the treatment arms I-II: The patients are randomized to two treatment arms

  1. 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 ½ tablet of 250 mg ASA or ½ 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 ½ 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double-blinded controlled trialRandomized double-blinded controlled trial
Masking:
Single (Care Provider)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)
Actual Study Start Date :
Jan 31, 2019
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Primaspan tablet 250 mg

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
Primaspan 250 mg tablet Acetyl Salicylic Acid
Other Names:
  • Primaspan 250 mg tablet

    		•
    Placebo Comparator: Placebo tablet

    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
    Placebo Oral Tablet
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in endoscopic Nasal polyp score of both sides of the nasal cavity. [at -4 days vs. at 11 months post-randomization]

      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.

    Secondary Outcome Measures

    1. 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 means differences between at time -4 days vs. +11 months post-randomization. A higher score means worse outcome.

    2. Change in the Relative forced expiratory volume in 1 second (FEV1%) without bronchodilator. [at -1 month vs. at 11 months post-randomization]

      Change means differences between at time -1 month vs. +11 months post-randomization. A higher value means better outcome. FEV1% is measured by Spirometry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    • ≥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.

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helsinki University Hospital Helsinki Finland 00029

    Sponsors and Collaborators

    • Sanna Salmi
    • University of Helsinki

    Investigators

    • Principal Investigator: Sanna Toppila-Salmi, MD PhD, Helsinki University Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanna Salmi, Senior Consultant Otorhinolaryngologist, PI, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT03825757
    Other Study ID Numbers:
    • TYH2018203
    • 2017-001570-42
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sanna Salmi, Senior Consultant Otorhinolaryngologist, PI, Helsinki University Central Hospital
    chronic rhinosinusitis with nasal polyps
    Acetyl salicylic acid exacerbated respiratory disease
    Additional relevant MeSH terms:
    Inflammation
    Aspirin
    Salicylic Acid
    Salicylates

    Study Results

    No Results Posted as of Aug 8, 2022