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

NCT01342601 | Completed

• 1 other identifier: PPL-041
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

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.

Conditions

Seasonal Allergic Rhinitis; Seasonal Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (8)

• clinically relevant changes in vital signs

  2 weeks

• Incidence of adverse events

  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)

  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

  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

  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

  2 weeks

• clinical relevant changes in physical examination parameters

  2 weeks

• Severity of Adverse events

  2 weeks

Secondary Outcomes (5)

• Use of rescue medication

  2 weeks

• TNSS, separately for a.m. and p.m. measurement over time

  2 weeks

• TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time

  2 weeks

• Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time

  2 weeks

• Symptom scores separately for a.m. and p.m. measurement over time

  2 weeks

Study Arms (2)

Ectoin products

ACTIVE COMPARATOR

Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)

Placebo products

PLACEBO COMPARATOR

Device: Placebo products

Interventions

ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) DEVICE

Comparison of ANS01 and AAT01 with placebo

Also known as: ect4allergy

Ectoin products

Placebo products DEVICE

Nasal Spray and Eye drops without Ectoin

Placebo products

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (8)

Kinderarzt Bleckmann

Baunatal-Großenritte, 34225, Germany

Location

Dr. med. Martina Weh

Berlin, 13125, Germany

Location

Experimentelle Pneumologie RUB

Bochum, 44789, Germany

Location

Kinderarztpraxis Bramsche

Bramsche, 49565, Germany

Location

Dr. med. Friedrich Kaiser

Hamburg, 22415, Germany

Location

Dr. Marlies Bölich

Jena, 07745, Germany

Location

Dr. Ralph Maier

Tuttlingen, 78532, Germany

Location

Dr.med. Dieter Schlegel und Lilli Hegai

Welzheim, 73642, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Albrecht Bufe, Prof. Dr. med.

  Experimentelle Pneumologie RUB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

DE (8)