AsthmaPhase 2NCT00961155
Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma
A Phase 2 study testing cyklezonid, montelukast sodium and formoterol 12 mcg twice daily in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- cyklezonid, montelukast sodium and formoterol 12 mcg twice daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2009to Jun 2014
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke
- healthy children
Who cannot join
- sensitization to allergens other than house dust mites
- other chronic diseases
- asthma exacerbation
- pregnancy
- oral corticosteroids for 4 weeks before the study
- montelukast sodium for 2 weeks before the study
Trial locations and contacts
1 site in 1 country.
Iwona Stelmach, MD PhD Prof contact
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Łódź Voivodeship
Joanna Jerzynska, MD PhD, 0048607153123, joannajerzynska@gmail.com
Joanna Jerzynska, MD PhD
About this study
Official title: Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma
Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.
Read the detailed description
Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in "asthma epidemic" in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment.
Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.
- Conditions
- Asthma
- Being tested
- cyklezonid, montelukast sodium, placebo, formoterol 12 mcg twice daily
- Keywords
- asthma, children, EBC, exposure to tabacco, antiasthma treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyklezonidDrug
Also called Alvesco
160 mcg once daily
montelukast sodiumDrug
5 or 10 mg according to age once daily
placeboDrug
fluticasone placebo twice daily, montelukast placebo once daily
formoterol 12 mcg twice dailyDrug
Also called Formoterol
formoterol 12 mcg twice daily will be given to children for 3 months
| Study group | Role | What they receive |
|---|---|---|
| cyklezonid | Active comparator | children will receive 160 mcg once daily cyklezonid for 3 months Receives: Drug: cyklezonid |
| montelukast sodium | Active comparator | children will receive 5 or 10 mg montelukast sodium for 3 months Receives: Drug: montelukast sodium |
| placebo | Placebo comparator | children will receive placebo for 8 weeks out of allergy season to house dust mite Receives: Drug: placebo |
| formoterol | Active comparator | children will receive formoterol aerolzol 12mcg twice daily for 3 months Receives: Drug: formoterol 12 mcg twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.
Measured: visit 1-6
Secondary outcomes (1)
Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation
Measured: visits 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Joanna Jerzynska, MD PhD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD PhD Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, PolandAgnieszka Brzozowska, MD, PhD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961155
- Sponsor's protocol ID
- RNN/137/08/KE
- Status last verified
- Dec 2013
- First submitted
- 17 Aug 2009
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma
- ClinicalTrials.gov ID
- NCT00961155
- Acronym / sponsor ID
- RNN/137/08/KE
- Conditions
- Asthma
- Keywords
- asthma, children, EBC, exposure to tabacco, antiasthma treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Aug 2009 (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.
Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.
Detailed description
Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in "asthma epidemic" in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment.
Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cyklezonid | Active comparator | Drug: cyklezonidchildren will receive 160 mcg once daily cyklezonid for 3 months |
| montelukast sodium | Active comparator | Drug: montelukast sodiumchildren will receive 5 or 10 mg montelukast sodium for 3 months |
| placebo | Placebo comparator | Drug: placebochildren will receive placebo for 8 weeks out of allergy season to house dust mite |
| formoterol | Active comparator | Drug: formoterol 12 mcg twice dailychildren will receive formoterol aerolzol 12mcg twice daily for 3 months |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke
- healthy children
Key exclusion criteria (6 listed)
- sensitization to allergens other than house dust mites
- other chronic diseases
- asthma exacerbation
- pregnancy
- oral corticosteroids for 4 weeks before the study
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 |
|---|---|---|
| cyklezonidAlso: Alvesco160 mcg once daily | Drug | cyklezonid |
| montelukast sodium5 or 10 mg according to age once daily | Drug | montelukast sodium |
| placebofluticasone placebo twice daily, montelukast placebo once daily | Drug | placebo |
| formoterol 12 mcg twice dailyAlso: Formoterolformoterol 12 mcg twice daily will be given to children for 3 months | Drug | formoterol |
Primary outcome
Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.
Time frame: visit 1-6
1 secondary outcome
Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation
Time frame: visits 1-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
Iwona Stelmach, MD PhD Prof contact
Joanna Jerzynska, MD PhD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD PhD Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Agnieszka Brzozowska, MD, PhD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyklezonid, montelukast sodium and formoterol 12 mcg twice daily in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
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 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 10 Dec 2013. 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 Poland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Joanna Jerzynska, MD PhD (0048607153123, joannajerzynska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood. (time frame: visit 1-6). 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 10 Dec 2013.