AsthmaNCT01562093
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
A study testing corticosteroid nasal spray in people with Asthma, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- corticosteroid nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Jun 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asthma (according to British Thoracic Society guideline)
- >18 years
Who cannot join
- pregnancy
- systemic disease with nasal manifestations
- cancer of the nose
- currently receiving cancer therapy
- previous nose surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.
Read the detailed description
Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.
The "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.
Conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.
The aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.
- Conditions
- Asthma
- Being tested
- corticosteroid nasal spray, placebo nasal spray
- Keywords
- Adrenal Cortex Hormones, Spirometry, Administration, Intranasal, Nasal blockage, Nasal sprays
- Medical subject headings
- Asthma, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroid nasal sprayDrug
Also called Avamys
fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months
placebo nasal sprayDrug
formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months
| Study group | Role | What they receive |
|---|---|---|
| local nasal steroids | Experimental | Not described Receives: Drug: corticosteroid nasal spray |
| placebo | Placebo comparator | Not described Receives: Drug: placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume
spirometry, methacholine and mannitol
Measured: up to 12 weeks
Secondary outcomes (4)
improvement in nasal blockage
Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
Measured: up to 12 weeks
nasal and exhaled NO
NO level in the nasal and exhaled air is measured by the chemiluminescence method with a LR 2000 nitric oxide gas analyser (Logan Research, Rochester, UK)
Measured: up to 12 weeks
wheeze
Pulmotrack wheeze meter
Measured: up to 12 weeks
subjective improvement in asthma symptomatology
Asthma Control Questionnaire
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Investigational drugs no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sverre Steinsvåg, MD prof, Study director, St. Olavs HospitalMalcolm Sue-Chu, MD, Principal investigator, St Olavs University Hospital TrondheimVegard Bugten, MD, Principal investigator, St Olavs University Hospital Trondheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562093
- Sponsor's protocol ID
- 2009/158
- Status last verified
- Aug 2016
- First submitted
- 21 Mar 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01562093
- Acronym / sponsor ID
- 2009/158
- Conditions
- Asthma
- Keywords
- Adrenal Cortex Hormones, Spirometry, Administration, Intranasal, Nasal blockage, Nasal sprays
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational drugs no longer available
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Mar 2012 (estimated)
- 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.
In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.
Detailed description
Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.
The "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.
Conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.
The aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.
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 |
|---|---|---|
| local nasal steroids | Experimental | Drug: corticosteroid nasal spray |
| placebo | Placebo comparator | Drug: placebo nasal spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asthma (according to British Thoracic Society guideline)
- >18 years
Key exclusion criteria (5 listed)
- pregnancy
- systemic disease with nasal manifestations
- cancer of the nose
- currently receiving cancer therapy
- previous nose surgery
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 |
|---|---|---|
| corticosteroid nasal sprayAlso: Avamysfluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months | Drug | local nasal steroids |
| placebo nasal sprayformula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months | Drug | placebo |
Primary outcome
forced expiratory volume
Time frame: up to 12 weeks
spirometry, methacholine and mannitol
4 secondary outcomes
improvement in nasal blockage
Time frame: up to 12 weeks
nasal and exhaled NO
Time frame: up to 12 weeks
wheeze
Time frame: up to 12 weeks
subjective improvement in asthma symptomatology
Time frame: up to 12 weeks
Results and safety
The study was stopped early (reason given: Investigational drugs no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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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.
Sverre Steinsvåg, MD prof study director
St. Olavs Hospital
Malcolm Sue-Chu, MD principal investigator
St Olavs University Hospital Trondheim
Vegard Bugten, MD principal investigator
St Olavs University Hospital Trondheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroid nasal spray in people with Asthma, run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Aug 2016. 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 Norway. 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?
The study was stopped early (reason given: Investigational drugs no longer available). 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?
forced expiratory volume (time frame: up to 12 weeks). 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 31 Aug 2016.