Chronic Rhinosinusitis Without Nasal PolypsAIR2022NCT05553951
Adherence in Global Airways
A study testing Intervention in people with Chronic Rhinosinusitis Without Nasal Polyps and Asthma, run by Christiane Haase at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps, Asthma, Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adherence to MARS- 5 L/N ≤35 at first visit
- Diagnosed with asthma (with and without allergic rhinitis) at initial visit
- Able to use smartphone
- ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma)
- Be over 18 years of age
- SNOT-22 score ≥35
- Diagnosed with CRSwNP
Who cannot join
- Adherence to MARS-5- L/N >35 points at first visit
- Do not have smartphone
- Does not read or speak English
- Other illness requiring regular medication
- Pregnancy and pregnancy that started during the study time period
- Servere psychological comorbidities
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Copenhagen, 2100
About this study
Official title: Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
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.
Read more
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
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps, Asthma, Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Controlgroup, Intervention
- Keywords
- Adherence, Nurse, Global airways, Astma, Chronic Rhinosinusitis with Nasal Polyps
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlgroupBehavioural
The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.
InterventionBehavioural
Patients in the intervention group will receive systematic and structured nursing guidance regarding their adherence, which includes proper use of nasal irrigation once or twice daily, nasal steroid/drops, use of inhaled medications, follow-up of smoking status. The intervention group will receive guidance videos which have been prepared prior to the study and will be standard for the intervention group. Guidance videos will cover the correct use of nasal irrigation, inhalation steroid, and nasal steroid/drops.
| Study group | Role | What they receive |
|---|---|---|
| Interventions group | Experimental | will receive systematic and structured nursing supervison about their adherence Receives: Behavioral: Intervention |
| Control group | Placebo comparator | Will receive usual care Receives: Behavioral: Controlgroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
Min. 0 point= non adherent, max. 25 point=adherent
Measured: 4 months
Secondary outcomes (7)
SNOT-22 - The Sino-Nasal Outcome Test 22
min. 0 point=no symptoms, max. 110 point=many symptoms.
Measured: 4 months
miniAQLQ - Mini asthma quality of life questionnaire
min. 1= all the time, max. 7= not at all
Measured: 4 months
HADS - Hospital Anxiety and Depression Scale
Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression
Measured: 4 months
STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
There is no minimum or maximum yet
Measured: 4 months
ACT - Asthma Control Test
min. 5 (poor control of asthma), max. 25 (complete control of asthma),
Measured: 4 months
ACQ-7 - Asthma Control Questionnaire
min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er > 1.5
Measured: 4 months
ESS - EPWORTH SLEEPINESS SCALE
min=0 point= normal sleep, max. 24 point= severe sleepiness.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Without Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiane Haase
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christiane Haase, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke P Backer, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553951
- Sponsor's protocol ID
- 2022-ENT-2- adherence
- Acronym
- AIR2022
- Status last verified
- Apr 2023
- First submitted
- 14 Sep 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
- ClinicalTrials.gov ID
- NCT05553951
- Acronym / sponsor ID
- AIR2022 / 2022-ENT-2- adherence
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps, Asthma, Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Adherence, Nurse, Global airways, Astma, Chronic Rhinosinusitis with Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Christiane HaaseUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventions group | Experimental | Behavioral: Interventionwill receive systematic and structured nursing supervison about their adherence |
| Control group | Placebo comparator | Behavioral: ControlgroupWill receive usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adherence to MARS- 5 L/N ≤35 at first visit
- Diagnosed with asthma (with and without allergic rhinitis) at initial visit
- Able to use smartphone
- ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma)
- Be over 18 years of age
Key exclusion criteria (6 listed)
- Adherence to MARS-5- L/N >35 points at first visit
- Do not have smartphone
- Does not read or speak English
- Other illness requiring regular medication
- Pregnancy and pregnancy that started during the study time period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlgroupThe control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose. | Behavioural | Control group |
| InterventionPatients in the intervention group will receive systematic and structured nursing guidance regarding their adherence, which includes proper use of nasal irrigation once or twice daily, nasal steroid/drops, use of inhaled medications, follow-up of smoking status. The intervention group will receive guidance videos which have been prepared prior to the study and will be standard for the intervention group. Guidance videos will cover the correct use of nasal irrigation, inhalation steroid, and nasal steroid/drops. | Behavioural | Interventions group |
Primary outcome
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
Time frame: 4 months
Min. 0 point= non adherent, max. 25 point=adherent
7 secondary outcomes
SNOT-22 - The Sino-Nasal Outcome Test 22
Time frame: 4 months
miniAQLQ - Mini asthma quality of life questionnaire
Time frame: 4 months
HADS - Hospital Anxiety and Depression Scale
Time frame: 4 months
STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
Time frame: 4 months
ACT - Asthma Control Test
Time frame: 4 months
ACQ-7 - Asthma Control Questionnaire
Time frame: 4 months
ESS - EPWORTH SLEEPINESS SCALE
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
Related trials for Chronic Rhinosinusitis Without Nasal Polyps
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 3
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Chronic Rhinosinusitis Without Nasal Polyps
RecruitingObservational study
CRS Questionnaire Validation Project
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
RecruitingPhase 4
Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke P Backer study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Chronic Rhinosinusitis Without Nasal Polyps and Asthma, run by Christiane Haase at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MARS-5 L/N - Medication adherence report scale both for upper and lower airways (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.