Observational Study With PASCALLERG ® in Patients With Hay Fever

Hay Fever Clinical Trial

Official title:

Observational Study With PASCALLERG ® in Patients With Hay Fever

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660737
• Other study ID #: 180A12PALL
• Status: Completed
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2021
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• hay fever

Exclusion Criteria:

• Lactose intolerance and / or
• Chromium hypersensitivity

Related Conditions & MeSH terms

• Fever
• Hay Fever
• Rhinitis, Allergic, Seasonal

Locations

Country	Name	City	State
Germany	Jennifer Lebert	Gießen

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Pascallerg	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)
Primary	Tolerability of Pascallerg	Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)	app. 4 weeks after baseline (treatment app. for 4 weeks)
Secondary	Numerical Rating Scale Well Beeing (Pre- Post)	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)
Secondary	Change of Symptom Dry Eyes (Pre- Post)	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)
Secondary	Change of Symptom Itching Eyes (Pre- Post)	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)
Secondary	Change of Symptom Burning Eyes (Pre-post)	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)
Secondary	Change of Symptom Bronchial Complaints (Pre-post)	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)
Secondary	Change of Symptom Sneezing (Pre-post)	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)
Secondary	Change of Symptom Rhinitis (Pre-post)	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)
Secondary	Change of Symtom Fatigue / Tiredness	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)
Secondary	Change of Symptom Headache (Pre-post)	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)
Secondary	Change of Symptom Tearing Eyes (Pre-post)	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)