Trial document





This trial has been registered retrospectively.
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  DRKS00009338

Trial Description

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Title

Non-interventional study and study according to §23b German Act on Medical Devices -
The use of alpha-tocopherolacetate (Filme Nasale)-nasal spray in patients with pollen-induced allergic rhinitis



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Trial Acronym

PA/Filme Nasale/D/2015

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Allergic disorders have increased greatly in recent decades. Many people suffer from hay fever caused by grass, tree or weed pollen. Allergic symptoms are alleviated mostly by using decongesting nasal sprays or allergy tablets which, however, can cause side effects in many patients. In contrast, “Filme Nasale” nasal spray is a medical device that does not contain any active pharmaceutical ingredients; instead it forms a protective film on the nasal mucosa and soothes it, upon which typical hay fever symptoms such as obstruction of the nose, sneezing, itching and a runny nose are supposed to disappear. No side effects are known to date. Patients aged 18 years or older suffering from hay fever can participate in this study and in the context of medical care are to be treated with either “Filme nasale” nasal spray, beclomethasone nasal spray or loratadine tablets.
Two visits one week apart are to take place at which the patient undergoes an examination of the nose and answers questions pertaining to hay fever symptoms and medications used. If a nasal spray is prescribed, the patient is asked to complete a sensory questionnaire upon applying the spray for the first time in the doctor’s office. During the one-week observation phase, the patient keeps a diary and enters in it his/her hay fever symptoms and any medication used.
This post-marketing surveillance study intends to investigate the extent to which “Filme nasale” nasal spray, compared with conventional hay fever medication, contributes to the relief or prevention of hay fever symptoms in a large patient population.

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Brief Summary in Scientific Language

Allergic rhinitis (AR) is a type 1 allergy that is accompanied by an inflammation of the nasal air passages and, among others, by an increase in immunoglobulin E (IgE) levels. Seasonal allergic rhinitis (SAR) is caused by various types of grass, tree and weed pollen.
The emphasis of rhinitis therapy is placed on symptomatic treatment with a pharmaceutical drug. Corticoid-containing nasal sprays are used that have anti-inflammatory and anti-allergic properties. As an alternative, oral and topical antihistamines can be administered which bind histamine H1 receptors, thereby reducing allergic reactions.
“Filme nasale” nasal spray is a medical device that contains alpha-tocopherol acetate (vitamin E acetate) and is an alternative treatment method for allergic rhinitis. Its efficacy and tolerability is to be investigated in this post-marketing surveillance study and compared with conventional therapies using beclomethasone nasal spray or loratadine tablets.

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Organizational Data

  •   DRKS00009338
  •   2015/09/29
  •   [---]*
  •   no
  •   Approved
  •   15-092, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J30.1 -  Allergic rhinitis due to pollen
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Interventions/Observational Groups

  •   Treatment of the allergic rhinitis with Filme Nasale-nasal spray
    Duration of treatment: 1 week,
    Frequency and dose: 2 squirts in each nostril at least 3 times a day as often
    as required (up to 6 times a day).
  •   Treatment of the allergic rhinitis with Beclometason-nasal spray,
    Duration of treatment: 1 week,
    Frequency and duration: 2 squirts in each nostril in the morning and in the evening
  •   Treatment of the allergic rhinitis with Loratadin-tablets,
    Duration of treatments: 1 week,
    Frequency and dose: 1 tablet per day
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The efficacy of Filme Nasale- (alpha-Tocopherolacetat-, Vitamin E-Acetat-) nasal spray will be investigated in comparison to Beclometason-nasal spray and Loratadin-tablets. The efficacy will be evaluated on the basis of the allergic symptoms and the intake of anti-allergic medication as documented in the diary (day 1 to 7).

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Secondary Outcome

The tolerability of the therapy will be evaluated by means of the rhinoscopy (Visit 1 on day 1 and vistit 2 on day 7), the documentation of adverse events (visit 2) and the assessment of the physician and patient (visit 2), respectively.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/04/27
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Pollen-induced allergic rhinitis

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Exclusion Criteria

According to the summary of product informations

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Addresses

  • start of 1:1-Block address primary-sponsor
    • PANIN s.r.l.
    • Ms.  Dr.  Franca Maria  Astolfi 
    • Viale della Scienza, 24
    • 45100  Rovigo
    • Italy
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    • Institut für Medizinische Informatik, Statistik und EpidemiologieUniklinik Köln
    • Mr.  Prof. Dr. med.  Ralph  Mösges 
    • Lindenburger Allee 42
    • 50931  Köln
    • Germany
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    • Institut für Medizinische Informatik, Statistik und EpidemiologieUniklinik Köln
    • Mr.  Prof. Dr. med.  Ralph  Mösges 
    • Lindenburger Allee 42
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • PANIN s.r.l.
    • Viale della Scienza, 24
    • 45100  Rovigo
    • Italy
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/12
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Trial Publications, Results and other Documents

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