Clinical trial NCT01342601: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Seasonal Allergic Conjunctivitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* - 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
* 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

Primary outcomes:
measure: clinically relevant changes in vital signs
timeFrame: 2 weeks
measure: Incidence of adverse events
timeFrame: 2 weeks
measure: 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)
timeFrame: 2 weeks
measure: Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
timeFrame: 2 weeks
measure: Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
timeFrame: 2 weeks
measure: Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
timeFrame: 2 weeks
measure: clinical relevant changes in physical examination parameters
timeFrame: 2 weeks
measure: Severity of Adverse events
timeFrame: 2 weeks
Secondary outcomes:
measure: Use of rescue medication
timeFrame: 2 weeks
measure: TNSS, separately for a.m. and p.m. measurement over time
timeFrame: 2 weeks
measure: TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
timeFrame: 2 weeks
measure: Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
timeFrame: 2 weeks
measure: Symptom scores separately for a.m. and p.m. measurement over time
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Baunatal-Großenritte
country: Germany
facility: Kinderarzt Bleckmann
city: Berlin
country: Germany
facility: Dr. med. Martina Weh
city: Bochum
country: Germany
facility: Experimentelle Pneumologie RUB
city: Bramsche
country: Germany
facility: Kinderarztpraxis Bramsche
city: Hamburg
country: Germany
facility: Dr. med. Friedrich Kaiser
city: Jena
country: Germany
facility: Dr. Marlies Bölich
city: Tuttlingen
country: Germany
facility: Dr. Ralph Maier
city: Welzheim
country: Germany
facility: Dr.med. Dieter Schlegel und Lilli Hegai
Study officials:
affiliation: Experimentelle Pneumologie RUB
name: Albrecht Bufe, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: