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
NCT ID: NCT01342601
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2011-04-30
2011-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ectoin products
ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Comparison of ANS01 and AAT01 with placebo
Placebo products
Placebo products
Nasal Spray and Eye drops without Ectoin
Interventions
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ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Comparison of ANS01 and AAT01 with placebo
Placebo products
Nasal Spray and Eye drops without Ectoin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
5 Years
17 Years
ALL
No
Sponsors
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Bitop AG
INDUSTRY
Responsible Party
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Principal Investigators
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Albrecht Bufe, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Experimentelle Pneumologie RUB
Locations
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Kinderarzt Bleckmann
Baunatal-Großenritte, , Germany
Dr. med. Martina Weh
Berlin, , Germany
Experimentelle Pneumologie RUB
Bochum, , Germany
Kinderarztpraxis Bramsche
Bramsche, , Germany
Dr. med. Friedrich Kaiser
Hamburg, , Germany
Dr. Marlies Bölich
Jena, , Germany
Dr. Ralph Maier
Tuttlingen, , Germany
Dr.med. Dieter Schlegel und Lilli Hegai
Welzheim, , Germany
Countries
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Other Identifiers
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PPL-041
Identifier Type: -
Identifier Source: org_study_id