Hay Fever Clinical Trial
Official title:
Observational Study With PASCALLERG ® in Patients With Hay Fever
| NCT number | NCT01660737 |
| Other study ID # | 180A12PALL |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2012 |
| Est. completion date | July 2013 |
| Verified date | March 2021 |
| Source | Pascoe Pharmazeutische Praeparate GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Jennifer Lebert | Gießen |
| Lead Sponsor | Collaborator |
|---|---|
| Pascoe Pharmazeutische Praeparate GmbH |
Germany,
| 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) |
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