Seasonal Allergic RhinitisNCT01342601
Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents
A study testing ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) in people with Seasonal Allergic Rhinitis and Seasonal Allergic Conjunctivitis, run by Bitop AG at 8 sites in Germany.
Trial summary
Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, Seasonal Allergic Conjunctivitis
- What is being tested?
- ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 8 sitesGermany
- Study dates
- Apr 2011to Sep 2011
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-17 years
- diagnosed seasonal allergic rhinitis
- general good health condition other than SAR, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation
- Sum of Total Nasal Score (TNSS) ≥ 6
- Sum of Total Ocular Score (TOSS) ≥ 4
Who cannot join
- - Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit)
- Chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids
- Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus
- Upper and lower airway respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in period
- Start of specific immunotherapy within 1 month preceding enrolment in the clinical investigation or change in dose of immunotherapy throughout the trial
Show all 9Show fewer
- Chronic moderate to severe asthma according to GINA criteria which is treated with inhaled corticosteroids (ICS) and additional anti-asthmatic treatment. Patients with mild co-seasonal asthma must not change their dose regimen of ICS within 4 weeks prior to the enrolment into the clinical investigation nor during the clinical investigation
- Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, emphysema, etc.)
- on investigators discretion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Kinderarzt Bleckmann
Baunatal-Großenritte, 34225
Dr. med. Martina Weh
Berlin, 13125
Experimentelle Pneumologie RUB
Bochum, 44789
Kinderarztpraxis Bramsche
Bramsche, 49565
Dr. med. Friedrich Kaiser
Hamburg, 22415
Dr. Marlies Bölich
Jena, 07745
Dr. Ralph Maier
Tuttlingen, 78532
Dr.med. Dieter Schlegel und Lilli Hegai
Welzheim, 73642
About this study
Official title: Evaluation of the Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents: a Multicenter, Double-blind, Randomised, Placebo Controlled, Parallel Group Clinical Investigation
Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events.
The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.
- Being tested
- ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01), Placebo products
- 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.
ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)Device
Also called ect4allergy
Comparison of ANS01 and AAT01 with placebo
Placebo productsDevice
Nasal Spray and Eye drops without Ectoin
| Study group | Role | What they receive |
|---|---|---|
| Ectoin products | Active comparator | Not described Receives: Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) |
| Placebo products | Placebo comparator | Not described Receives: Device: Placebo products |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically relevant changes in vital signs
Measured: 2 weeks
Incidence of adverse events
Measured: 2 weeks
Overall assessment by the patient (Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ for children aged 5-12 years or AdolRQLQ for adolescents aged 13-17 years)
Measured: 2 weeks
Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Total nasal symptom score: runny nose (anterior rhinorrhea/postnasal drainage), itchy nose, nasal congestion (stuffy nose) and sneezing on a 4 point scale (0=none to 3= severe)asssessed by the patient/caregiver
Measured: 2 weeks
Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Total ocular symptom score: itchy eyes, red eyes, watery eyes´on a 4 point scale (0=none to 3=severe) assessed by the patient/caregiver
Measured: 2 weeks
Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Non-nasal score: itchy ear/palate on a 4 point scale (0=none to 3=severe)assessed by the patient/caregiver
Measured: 2 weeks
clinical relevant changes in physical examination parameters
Measured: 2 weeks
Severity of Adverse events
Measured: 2 weeks
Secondary outcomes (5)
Use of rescue medication
Measured: 2 weeks
TNSS, separately for a.m. and p.m. measurement over time
Measured: 2 weeks
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
Measured: 2 weeks
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
Measured: 2 weeks
Symptom scores separately for a.m. and p.m. measurement over time
Symptom scores: Runny nose, itchy nose, nasal congestion, Sneezing, itchy ear, itchy eyes, red eyes, watery eyes
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albrecht Bufe, Prof. Dr. med., Principal investigator, Experimentelle Pneumologie RUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342601
- Sponsor's protocol ID
- PPL-041
- Status last verified
- Oct 2011
- First submitted
- 21 Apr 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents: a Multicenter, Double-blind, Randomised, Placebo Controlled, Parallel Group Clinical Investigation
- ClinicalTrials.gov ID
- NCT01342601
- Acronym / sponsor ID
- PPL-041
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Apr 2011 (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.
Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events.
The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.
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 |
|---|---|---|
| Ectoin products | Active comparator | Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) |
| Placebo products | Placebo comparator | Device: Placebo products |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5-17 years
- diagnosed seasonal allergic rhinitis
- general good health condition other than SAR, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation
- Sum of Total Nasal Score (TNSS) ≥ 6
- Sum of Total Ocular Score (TOSS) ≥ 4
Key exclusion criteria (9 listed)
- - Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit)
- Chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids
- Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus
- Upper and lower airway respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in 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 |
|---|---|---|
| ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)Also: ect4allergyComparison of ANS01 and AAT01 with placebo | Device | Ectoin products |
| Placebo productsNasal Spray and Eye drops without Ectoin | Device | Placebo products |
Primary outcome
clinically relevant changes in vital signs
Time frame: 2 weeks
Incidence of adverse events
Time frame: 2 weeks
Overall assessment by the patient (Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ for children aged 5-12 years or AdolRQLQ for adolescents aged 13-17 years)
Time frame: 2 weeks
Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Time frame: 2 weeks
Total nasal symptom score: runny nose (anterior rhinorrhea/postnasal drainage), itchy nose, nasal congestion (stuffy nose) and sneezing on a 4 point scale (0=none to 3= severe)asssessed by the patient/caregiver
Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Time frame: 2 weeks
Total ocular symptom score: itchy eyes, red eyes, watery eyes´on a 4 point scale (0=none to 3=severe) assessed by the patient/caregiver
Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Time frame: 2 weeks
Non-nasal score: itchy ear/palate on a 4 point scale (0=none to 3=severe)assessed by the patient/caregiver
clinical relevant changes in physical examination parameters
Time frame: 2 weeks
Severity of Adverse events
Time frame: 2 weeks
5 secondary outcomes
Use of rescue medication
Time frame: 2 weeks
TNSS, separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
Symptom scores separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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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.
Albrecht Bufe, Prof. Dr. med. principal investigator
Experimentelle Pneumologie RUB
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) in people with Seasonal Allergic Rhinitis and Seasonal Allergic Conjunctivitis, run by Bitop AG at 8 sites in Germany.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinically relevant changes in vital signs (time frame: 2 weeks). The study lists 8 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 13 Oct 2011.