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Completed

NCT Number: NCT01660737

Observational Study With PASCALLERG ® in Patients With Hay Fever

The aim of this observational study is to document the therapeutic use of PASCALLERG ® for hay fever. Based on the survey is a decrease in disease-specific symptoms when taking PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility can be assessed.

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Key information

Conditions

Hay Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jennifer Lebert

Giessen, 35390, Germany

About this study

There are documented male and female patients over the age of one year who suffer from hay fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hay fever

Exclusion criteria

  • Lactose intolerance and / or
  • Chromium hypersensitivity

Treatment and study plan

Primary outcomes

  1. Efficacy of Pascallerg

    Time frame: appr. 4 weeks after baseline (after appr. 4 weeks of treatment)

    Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)

  2. Tolerability of Pascallerg

    Time frame: app. 4 weeks after baseline (treatment app. for 4 weeks)

    Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)

Secondary outcomes

  1. Numerical Rating Scale Well Beeing (Pre- Post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)

  2. Change of Symptom Dry Eyes (Pre- Post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  3. Change of Symptom Itching Eyes (Pre- Post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  4. Change of Symptom Burning Eyes (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  5. Change of Symptom Bronchial Complaints (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  6. Change of Symptom Sneezing (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  7. Change of Symptom Rhinitis (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  8. Change of Symtom Fatigue / Tiredness

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  9. Change of Symptom Headache (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

  10. Change of Symptom Tearing Eyes (Pre-post)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2012
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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