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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT01342601
First received: April 21, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Seasonal Allergic Rhinitis
Seasonal Allergic Conjunctivitis
Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Device: Placebo products

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

Resource links provided by NLM:


Further study details as provided by Bitop AG:

Primary Outcome Measures:
  • clinically relevant changes in vital signs [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Severity of Adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • TNSS, separately for a.m. and p.m. measurement over time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Symptom scores separately for a.m. and p.m. measurement over time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Symptom scores: Runny nose, itchy nose, nasal congestion, Sneezing, itchy ear, itchy eyes, red eyes, watery eyes


Enrollment: 72
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ectoin products Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
Comparison of ANS01 and AAT01 with placebo
Other Name: ect4allergy
Placebo Comparator: Placebo products Device: Placebo products
Nasal Spray and Eye drops without Ectoin

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342601

Locations
Germany
Kinderarzt Bleckmann
Baunatal-Großenritte, Germany, 34225
Dr. med. Martina Weh
Berlin, Germany, 13125
Experimentelle Pneumologie RUB
Bochum, Germany, 44789
Kinderarztpraxis Bramsche
Bramsche, Germany, 49565
Dr. med. Friedrich Kaiser
Hamburg, Germany, 22415
Dr. Marlies Bölich
Jena, Germany, 07745
Dr. Ralph Maier
Tuttlingen, Germany, 78532
Dr.med. Dieter Schlegel und Lilli Hegai
Welzheim, Germany, 73642
Sponsors and Collaborators
Bitop AG
Investigators
Principal Investigator: Albrecht Bufe, Prof. Dr. med. Experimentelle Pneumologie RUB
  More Information

No publications provided

Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT01342601     History of Changes
Other Study ID Numbers: PPL-041
Study First Received: April 21, 2011
Last Updated: October 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014