Observational Study With PASCALLERG ® in Patients With Hay Fever

Completed

• Conditions: Hay Fever

• Registration Number: NCT01660737
• Lead Sponsor: Pascoe Pharmazeutische Praeparate GmbH

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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2016-04-21
• Results First Submitted QC: 2017-04-04
• Results First Posted: 2017-06-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• hay fever

Exclusion Criteria

• Lactose intolerance and / or
• Chromium hypersensitivity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Pascallerg	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)
Tolerability of Pascallerg	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

Name	Time	Method
Change of Symptom Bronchial Complaints (Pre-post)	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 of Symptom Headache (Pre-post)	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 of Symptom Tearing Eyes (Pre-post)	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 of Symptom Dry Eyes (Pre- Post)	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 of Symptom Itching Eyes (Pre- Post)	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 of Symptom Rhinitis (Pre-post)	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)
Numerical Rating Scale Well Beeing (Pre- Post)	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 of Symptom Burning Eyes (Pre-post)	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 of Symptom Sneezing (Pre-post)	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 of Symtom Fatigue / Tiredness	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)

Trial Locations

Locations (1)

Jennifer Lebert; 🇩🇪 Gießen, Germany