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Observational Study With PASCALLERG ® in Patients With Hay Fever

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ClinicalTrials.gov Identifier: NCT01660737
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Hay Fever

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 Design

Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study With PASCALLERG ® in Patients With Hay Fever
Study Start Date : February 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Hay Fever
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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 [ 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 Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients from natural practioners and doctors from Germany
Criteria

Inclusion Criteria:

  • hay fever

Exclusion Criteria:

  • Lactose intolerance and / or
  • Chromium hypersensitivity
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660737


Locations
Germany
Jennifer Lebert
Gießen, Germany, 35390
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01660737     History of Changes
Other Study ID Numbers: 180A12PALL
First Posted: August 9, 2012    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: April 2017

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
Hay fever
Pascallerg

Additional relevant MeSH terms:
Fever
Rhinitis, Allergic, Seasonal
Body Temperature Changes
Signs and Symptoms
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases