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NCT05553951: AIR2022
Adherence in Global Airways
NA trial testing Controlgroup in Chronic Rhinosinusitis Without Nasal Polyps in 90 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Christiane Haase |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Controlgroup
- Intervention
Conditions studied
- Chronic Rhinosinusitis Without Nasal Polyps — all drugs for Chronic Rhinosinusitis Without Nasal Polyps →
- Asthma — all drugs for Asthma →
- Chronic Rhinosinusitis With Nasal Polyps — all drugs for Chronic Rhinosinusitis With Nasal Polyps →
- Chronic Rhinosinusitis (Diagnosis) — all drugs for Chronic Rhinosinusitis (Diagnosis) →
Sponsor
Christiane Haase
Who can join
Adults 18 to 100, any sex, with Chronic Rhinosinusitis Without Nasal Polyps or Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS. Several studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS. Aim: To investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence. Hypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care. In a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance. Primary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance. Inclusion Criteria: Adherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), \>18 years of age, SNOT-22 score ≥35 Exclusion Criteria: * Adherence to MARS-5- L/N \>35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities Questionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05553951
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Related trials
Other recruiting trials for Chronic Rhinosinusitis Without Nasal Polyps
Currently open trials in the same condition.
- NCT06850805 — Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Witho · Phase 3 · recruiting
- NCT06691113 — A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants · Phase 2 · active not recruiting
- NCT06398873 — Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP · recruiting
- NCT06069310 — Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma · active not recruiting
- NCT05642806 — Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment · Phase 4 · recruiting
Other Christiane Haase trials
Trials by the same sponsor.
- NCT05843019 — Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05553951 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Christiane Haase
- Last refreshed: 20 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05553951.
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