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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

Primary Purpose

Seasonal Allergic Rhinitis, Seasonal Allergic Conjunctivitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Placebo products
Sponsored by
Bitop AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinderarzt Bleckmann
  • Dr. med. Martina Weh
  • Experimentelle Pneumologie RUB
  • Kinderarztpraxis Bramsche
  • Dr. med. Friedrich Kaiser
  • Dr. Marlies Bölich
  • Dr. Ralph Maier
  • Dr.med. Dieter Schlegel und Lilli Hegai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ectoin products

Placebo products

Arm Description

Outcomes

Primary Outcome Measures

clinically relevant changes in vital signs
Incidence of adverse events
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)
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
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
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
clinical relevant changes in physical examination parameters
Severity of Adverse events

Secondary Outcome Measures

Use of rescue medication
TNSS, separately for a.m. and p.m. measurement over time
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
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

Full Information

First Posted
April 21, 2011
Last Updated
October 12, 2011
Sponsor
Bitop AG
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1. Study Identification

Unique Protocol Identification Number
NCT01342601
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bitop AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Seasonal Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ectoin products
Arm Type
Active Comparator
Arm Title
Placebo products
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Other Intervention Name(s)
ect4allergy
Intervention Description
Comparison of ANS01 and AAT01 with placebo
Intervention Type
Device
Intervention Name(s)
Placebo products
Intervention Description
Nasal Spray and Eye drops without Ectoin
Primary Outcome Measure Information:
Title
clinically relevant changes in vital signs
Time Frame
2 weeks
Title
Incidence of adverse events
Time Frame
2 weeks
Title
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
Title
Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Description
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
Time Frame
2 weeks
Title
Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Description
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
Time Frame
2 weeks
Title
Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Description
Non-nasal score: itchy ear/palate on a 4 point scale (0=none to 3=severe)assessed by the patient/caregiver
Time Frame
2 weeks
Title
clinical relevant changes in physical examination parameters
Time Frame
2 weeks
Title
Severity of Adverse events
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Use of rescue medication
Time Frame
2 weeks
Title
TNSS, separately for a.m. and p.m. measurement over time
Time Frame
2 weeks
Title
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
Time Frame
2 weeks
Title
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
Time Frame
2 weeks
Title
Symptom scores separately for a.m. and p.m. measurement over time
Description
Symptom scores: Runny nose, itchy nose, nasal congestion, Sneezing, itchy ear, itchy eyes, red eyes, watery eyes
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albrecht Bufe, Prof. Dr. med.
Organizational Affiliation
Experimentelle Pneumologie RUB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinderarzt Bleckmann
City
Baunatal-Großenritte
ZIP/Postal Code
34225
Country
Germany
Facility Name
Dr. med. Martina Weh
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Experimentelle Pneumologie RUB
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Kinderarztpraxis Bramsche
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Facility Name
Dr. med. Friedrich Kaiser
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Dr. Marlies Bölich
City
Jena
ZIP/Postal Code
07745
Country
Germany
Facility Name
Dr. Ralph Maier
City
Tuttlingen
ZIP/Postal Code
78532
Country
Germany
Facility Name
Dr.med. Dieter Schlegel und Lilli Hegai
City
Welzheim
ZIP/Postal Code
73642
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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