Observational Study With PASCALLERG ® in Patients With Hay Fever

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01660737

Enrollment

123

Registered

2012-08-09

Start date

2012-02-29

Completion date

2013-07-31

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hay Fever

Keywords

Hay fever, Pascallerg

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

* hay fever

Exclusion criteria

* Lactose intolerance and / or * Chromium hypersensitivity

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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 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 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)
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 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)
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)

Countries

Germany

Participant flow

Participants by arm

Arm	Count
PASCALLERG® Tablets in Patients With Hay Fever Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.	123
Total	123

Baseline characteristics

Characteristic	PASCALLERG® Tablets in Patients With Hay Fever
Age, Categorical <=18 years	30 Participants
Age, Categorical >=65 years	9 Participants
Age, Categorical Between 18 and 65 years	84 Participants
Age, Continuous	36.00 years STANDARD_DEVIATION 18.9
Region of Enrollment Germany	123 participants
Sex: Female, Male Female	65 Participants
Sex: Female, Male Male	58 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 123
serious Total, serious adverse events	0 / 123

Outcome results

Primary

Efficacy of Pascallerg

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

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

Arm	Measure	Group	Value (NUMBER)
PASCALLERG® Tablets in Patients With Hay Fever	Efficacy of Pascallerg	Very good efficacy (symptoms complete decline)	60 participants
PASCALLERG® Tablets in Patients With Hay Fever	Efficacy of Pascallerg	Good efficacy (symptoms clearly improved)	44 participants
PASCALLERG® Tablets in Patients With Hay Fever	Efficacy of Pascallerg	Moderate efficacy (smptoms slightly improved)	15 participants
PASCALLERG® Tablets in Patients With Hay Fever	Efficacy of Pascallerg	No efficacy (symptoms unchanged o worsend)	2 participants
PASCALLERG® Tablets in Patients With Hay Fever	Efficacy of Pascallerg	No data available	2 participants

Primary

Tolerability of Pascallerg

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

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

Arm	Measure	Group	Value (NUMBER)
PASCALLERG® Tablets in Patients With Hay Fever	Tolerability of Pascallerg	Very good	122 participants
PASCALLERG® Tablets in Patients With Hay Fever	Tolerability of Pascallerg	Bad tolerability	1 participants

Secondary