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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

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

April 21, 2011
October 12, 2011
April 2011
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01342601 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Seasonal Allergic Rhinitis
  • Seasonal Allergic Conjunctivitis
  • Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
    Comparison of ANS01 and AAT01 with placebo
    Other Name: ect4allergy
  • Device: Placebo products
    Nasal Spray and Eye drops without Ectoin
  • Active Comparator: Ectoin products
    Intervention: Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
  • Placebo Comparator: Placebo products
    Intervention: Device: Placebo products
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01342601
PPL-041
No
Bitop AG
Bitop AG
Not Provided
Principal Investigator: Albrecht Bufe, Prof. Dr. med. Experimentelle Pneumologie RUB
Bitop AG
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP