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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342601
• Other study ID #: PPL-041
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: October 12, 2011
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Conjunctivitis
• Seasonal Allergic Rhinitis

Intervention

Device:
• ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Comparison of ANS01 and AAT01 with placebo
• Placebo products
Nasal Spray and Eye drops without Ectoin

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically relevant changes in vital signs		2 weeks	Yes
Primary	Incidence of adverse events		2 weeks	Yes
Primary	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)		2 weeks	Yes
Primary	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	2 weeks	No
Primary	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	2 weeks	No
Primary	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	2 weeks	No
Primary	clinical relevant changes in physical examination parameters		2 weeks	Yes
Primary	Severity of Adverse events		2 weeks	Yes
Secondary	Use of rescue medication		2 weeks	Yes
Secondary	TNSS, separately for a.m. and p.m. measurement over time		2 weeks	No
Secondary	TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time		2 weeks	No
Secondary	Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time		2 weeks	No
Secondary	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	2 weeks	No