PollinosisPhase 4POLETNCT01785394
POLlinosis and Exhaled Breath Temperature
A Phase 4 study testing 5 grass allergen extract in people with Pollinosis, run by Prof. Todor Popov at 1 site in Bulgaria.
Trial summary
The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Pollinosis
- What is being tested?
- 5 grass allergen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBulgaria
- Study dates
- Feb 2012to Oct 2013
- Phase
- Phase 4
- 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 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 60 randomized patients from either sex
- age range 5-55 years
- included patients should have a proven grass pollen sensitization
Who cannot join
- age under or above the stated
- lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical University Sofia, Department of Allergology
Sofia, 1431
About this study
Official title: Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.
Read the detailed description
Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.
Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.
Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.
Statistical analysis: On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level <0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.
- Conditions
- Pollinosis
- Being tested
- 5 grass allergen extract
- Keywords
- pollinosis, sublingual immunotherapy, exhaled breath temperature
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 grass allergen extractDrug
Also called Staloral
30 patients will be subjected to sublingual immunotherapy with 5 grass allergen extract Staloral, starting with 1 spurt of 10 IR/ml increasing them daily stepwise to 10 spurts, switching then to 1 spurt of 300 IR/ml, increasing daily stepwise to 10 spurts, and then maintaining this dose from February till July. 30 patients will be on placebo.
| Study group | Role | What they receive |
|---|---|---|
| 5 grass allergen extract | Active comparator | 30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July) Receives: Drug: 5 grass allergen extract |
| Placebo | Placebo comparator | 30 patients will receive placebo Receives: Drug: 5 grass allergen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients.
The primary objective of the study is to evaluate the differences between the changes of exhaled breath temperature before and in the pollen season of subjects treated with 5 grass allergen extract applied sublingually and untreated control patients. Possible carry-over differences between the same two arms will be explored during the second year of the trial. Calculations will involve difference between assessment at month 6 and baseline for year 1 (2012) and in year 2 (2013) and comparisons between the two arms of the study will be made.
Measured: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Secondary outcomes (1)
Effect of the treatment on symptoms and objective measurements in blood
Changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage, changes in blood cell counts, C-reactive protein, IL13 and periostin will be calculated (difference between assessment at month 6 and baseline) for year 1 (2012) and Year 2 (2013) and compared between the two arms of the study.
Measured: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PollinosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Todor Popov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Todor Popov, Association Asthma, Bulgaria
- Investigators
- Todor Popov, MD, PhD, Principal investigator, Professor of Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785394
- Sponsor's protocol ID
- POLET-12-13
- Acronym
- POLET
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xepapadaki P, Xatziioannou A, Chatzicharalambous M, Makrinioti H, Papadopoulos NG. Exhaled breath temperature increases during mild exacerbations in children with virus-induced asthma. Int Arch Allergy Immunol. 2010;153(1):70-4. doi: 10.1159/000301581. Epub 2010 Apr 1.
PubMed 20357487Popov TA, Kralimarkova T, Tzachev C, Dimitrov V, Mun KK, Gill J. Exhaled breath temperature measurement made easy. Pediatr Allergy Immunol. 2009 Mar;20(2):200-1; author reply 202-3. doi: 10.1111/j.1399-3038.2008.00837.x. Epub 2008 Nov 10. No abstract available.
PubMed 19017281Popov TA, Dunev S, Kralimarkova TZ, Kraeva S, DuBuske LM. Evaluation of a simple, potentially individual device for exhaled breath temperature measurement. Respir Med. 2007 Oct;101(10):2044-50. doi: 10.1016/j.rmed.2007.06.005. Epub 2007 Jul 12.
PubMed 17624752Braunstahl GJ, Hellings PW. Nasobronchial interaction mechanisms in allergic airways disease. Curr Opin Otolaryngol Head Neck Surg. 2006 Jun;14(3):176-82. doi: 10.1097/01.moo.0000193186.15440.39.
PubMed 16728896Kralimarkova TZ, Popov TA, Staevska M, Mincheva R, Lazarova C, Racheva R, Mustakov TB, Filipova V, Koleva M, Bacheva K, Dimitrov VD. Objective approach for fending off the sublingual immunotherapy placebo effect in subjects with pollenosis: double-blinded, placebo-controlled trial. Ann Allergy Asthma Immunol. 2014 Jul;113(1):108-13. doi: 10.1016/j.anai.2014.03.019. Epub 2014 Apr 16.
PubMed 24745701
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
- ClinicalTrials.gov ID
- NCT01785394
- Acronym / sponsor ID
- POLET / POLET-12-13
- Conditions
- Pollinosis
- Keywords
- pollinosis, sublingual immunotherapy, exhaled breath temperature
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Todor PopovUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 Feb 2013 (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.
The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.
Detailed description
Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.
Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.
Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.
Statistical analysis: On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level <0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 grass allergen extract | Active comparator | Drug: 5 grass allergen extract30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July) |
| Placebo | Placebo comparator | Drug: 5 grass allergen extract30 patients will receive placebo |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 60 randomized patients from either sex
- age range 5-55 years
- included patients should have a proven grass pollen sensitization
Key exclusion criteria (2 listed)
- age under or above the stated
- lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen
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 |
|---|---|---|
| 5 grass allergen extractAlso: Staloral30 patients will be subjected to sublingual immunotherapy with 5 grass allergen extract Staloral, starting with 1 spurt of 10 IR/ml increasing them daily stepwise to 10 spurts, switching then to 1 spurt of 300 IR/ml, increasing daily stepwise to 10 spurts, and then maintaining this dose from February till July. 30 patients will be on placebo. | Drug | 5 grass allergen extract, Placebo |
Primary outcome
Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients.
Time frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
The primary objective of the study is to evaluate the differences between the changes of exhaled breath temperature before and in the pollen season of subjects treated with 5 grass allergen extract applied sublingually and untreated control patients. Possible carry-over differences between the same two arms will be explored during the second year of the trial. Calculations will involve difference between assessment at month 6 and baseline for year 1 (2012) and in year 2 (2013) and comparisons between the two arms of the study will be made.
1 secondary outcome
Effect of the treatment on symptoms and objective measurements in blood
Time frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Background: PubMed 20357487Xepapadaki P, Xatziioannou A, Chatzicharalambous M, Makrinioti H, Papadopoulos NG. Exhaled breath temperature increases during mild exacerbations in children with virus-induced asthma. Int Arch Allergy Immunol. 2010;153(1):70-4. doi: 10.1159/000301581. Epub 2010 Apr 1.
- Background: PubMed 19017281Popov TA, Kralimarkova T, Tzachev C, Dimitrov V, Mun KK, Gill J. Exhaled breath temperature measurement made easy. Pediatr Allergy Immunol. 2009 Mar;20(2):200-1; author reply 202-3. doi: 10.1111/j.1399-3038.2008.00837.x. Epub 2008 Nov 10. No abstract available.
- Background: PubMed 17624752Popov TA, Dunev S, Kralimarkova TZ, Kraeva S, DuBuske LM. Evaluation of a simple, potentially individual device for exhaled breath temperature measurement. Respir Med. 2007 Oct;101(10):2044-50. doi: 10.1016/j.rmed.2007.06.005. Epub 2007 Jul 12.
- Background: PubMed 16728896Braunstahl GJ, Hellings PW. Nasobronchial interaction mechanisms in allergic airways disease. Curr Opin Otolaryngol Head Neck Surg. 2006 Jun;14(3):176-82. doi: 10.1097/01.moo.0000193186.15440.39.
- Derived from this study: PubMed 24745701Kralimarkova TZ, Popov TA, Staevska M, Mincheva R, Lazarova C, Racheva R, Mustakov TB, Filipova V, Koleva M, Bacheva K, Dimitrov VD. Objective approach for fending off the sublingual immunotherapy placebo effect in subjects with pollenosis: double-blinded, placebo-controlled trial. Ann Allergy Asthma Immunol. 2014 Jul;113(1):108-13. doi: 10.1016/j.anai.2014.03.019. Epub 2014 Apr 16.
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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.
Todor Popov, MD, PhD principal investigator
Professor of Allergology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5 grass allergen extract in people with Pollinosis, run by Prof. Todor Popov at 1 site in Bulgaria.
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 3 inclusion and 2 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 7 Feb 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 Bulgaria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients. (time frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785394, which also lists 5 linked publications.
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 7 Feb 2013.