Observational Study With PASCALLERG ® in Patients With Hay Fever

March 9, 2021 updated by: Pascoe Pharmazeutische Praeparate GmbH
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gießen, Germany, 35390
        • Jennifer Lebert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients from natural practioners and doctors from Germany

Description

Inclusion Criteria:

  • hay fever

Exclusion Criteria:

  • Lactose intolerance and / or
  • Chromium hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PASCALLERG® tablets in patients with hay fever
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
appr. 4 weeks after baseline (after appr. 4 weeks of treatment)
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)
app. 4 weeks after baseline (treatment app. for 4 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pascoe Pharmazeutische Praeparate GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (ESTIMATE)

August 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180A12PALL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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