AsthmaNCT03718793
Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes
A study testing Peripheral exhaled nitric oxide in people with Asthma, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls. Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Peripheral exhaled nitric oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- 15 Feb 2019to 1 Dec 2024
- 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 4 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
- significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
- in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
- significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)
Who cannot join
- current smoking
- regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
- other chronic pulmonary disease
- other diseases that in the opinion of the treating physician prevents participation
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Allergy Centre, Tampere University Hospital
Tampere, 33521
Lauri Lehtimäki, MD, +358 405562769, lauri.lehtimaki@gmail.com
Iida Ojaniemi, MD, +358 45 8774575, iida.ojaniemi@gmail.com
About this study
Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.
- Conditions
- Asthma
- Being tested
- Peripheral exhaled nitric oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral exhaled nitric oxideDiagnostic test
Also called Impulse oscillometry, ECP/B-eos ratio
Small airway inflammation and dysfunction will be measured using the above mentioned tests.
| Study group | Role | What they receive |
|---|---|---|
| All subjects with asthma | Experimental | In addition to normal diagnostic work out we will measure small airway inflammation based on peripheral exhaled nitric oxide and assess small airway dysfunction using impulse oscillometry. In addition, inflammatory markers in peripheral blood and genotype will be assessed. Receives: Diagnostic Test: Peripheral exhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
Change in peripheral NO output
Measured: Baseline
Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma
Change in peripheral airway resistance
Measured: Baseline
Secondary outcomes (3)
Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls
ECP/B-Eos ratio will calculated by dividing serum level of ECP by peripheral blood eosinophil count.
Measured: Baseline
Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma
ECP/B-Eos ratio will be calculated as above. Peripheral exhaled NO output will be calculated based on exhaled NO measurement at multiple flow rates.
Measured: Baseline
Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma
ECP/B-Eos ratio will be calculated as above. Peripheral airway resistance will be calculated as R5-R20 based on impulse oscillometry.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start15 Feb 2019
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauri Lehtimäki, Tampere University Hospital
- Investigators
- Lauri Lehtimäki, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718793
- Sponsor's protocol ID
- R17004
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2018
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes
- ClinicalTrials.gov ID
- NCT03718793
- Acronym / sponsor ID
- R17004
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Oct 2018 (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.
Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects with asthma | Experimental | Diagnostic Test: Peripheral exhaled nitric oxideIn addition to normal diagnostic work out we will measure small airway inflammation based on peripheral exhaled nitric oxide and assess small airway dysfunction using impulse oscillometry. In addition, inflammatory markers in peripheral blood and genotype will be assessed. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
- significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
- in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
- significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)
Key exclusion criteria (4 listed)
- current smoking
- regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
- other chronic pulmonary disease
- other diseases that in the opinion of the treating physician prevents participation
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 |
|---|---|---|
| Peripheral exhaled nitric oxideAlso: Impulse oscillometry, ECP/B-eos ratioSmall airway inflammation and dysfunction will be measured using the above mentioned tests. | Diagnostic test | All subjects with asthma |
Primary outcome
Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
Time frame: Baseline
Change in peripheral NO output
Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma
Time frame: Baseline
Change in peripheral airway resistance
3 secondary outcomes
Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls
Time frame: Baseline
Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma
Time frame: Baseline
Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Lauri Lehtimäki, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral exhaled nitric oxide in people with Asthma, run by Tampere University Hospital at 1 site in Finland.
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 4 inclusion and 4 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 4 Jan 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 Finland. 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. 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?
Contact Lauri Lehtimäki, MD (+358 40 5562769, lauri.lehtimaki@uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma (time frame: Baseline). The study lists 2 primary outcomes in all. 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 4 Jan 2023.