Trial Outcomes & Findings for Observational Study With PASCALLERG ® in Patients With Hay Fever (NCT NCT01660737)
NCT ID: NCT01660737
Last Updated: 2021-03-30
Results Overview
Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)
Recruitment status
COMPLETED
Target enrollment
123 participants
Primary outcome timeframe
appr. 4 weeks after baseline (after appr. 4 weeks of treatment)
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
COMPLETED
|
123
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study With PASCALLERG ® in Patients With Hay Fever
Baseline characteristics by cohort
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=123 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
36.00 years
STANDARD_DEVIATION 18.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
123 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=123 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Efficacy of Pascallerg
Very good efficacy (symptoms complete decline)
|
60 participants
|
|
Efficacy of Pascallerg
Good efficacy (symptoms clearly improved)
|
44 participants
|
|
Efficacy of Pascallerg
Moderate efficacy (smptoms slightly improved)
|
15 participants
|
|
Efficacy of Pascallerg
No efficacy (symptoms unchanged o worsend)
|
2 participants
|
|
Efficacy of Pascallerg
No data available
|
2 participants
|
PRIMARY outcome
Timeframe: app. 4 weeks after baseline (treatment app. for 4 weeks)Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=123 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Tolerability of Pascallerg
Very good
|
122 participants
|
|
Tolerability of Pascallerg
Bad tolerability
|
1 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=115 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Numerical Rating Scale Well Beeing (Pre- Post)
improved
|
109 participants
|
|
Numerical Rating Scale Well Beeing (Pre- Post)
unchanged
|
4 participants
|
|
Numerical Rating Scale Well Beeing (Pre- Post)
detoriorated
|
2 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=45 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Dry Eyes (Pre- Post)
improved
|
36 participants
|
|
Change of Symptom Dry Eyes (Pre- Post)
unchanged
|
9 participants
|
|
Change of Symptom Dry Eyes (Pre- Post)
deteriorated
|
0 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=101 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Itching Eyes (Pre- Post)
improved
|
87 participants
|
|
Change of Symptom Itching Eyes (Pre- Post)
unchanged
|
10 participants
|
|
Change of Symptom Itching Eyes (Pre- Post)
deteriorated
|
4 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=76 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Burning Eyes (Pre-post)
improved
|
68 participants
|
|
Change of Symptom Burning Eyes (Pre-post)
unchanged
|
6 participants
|
|
Change of Symptom Burning Eyes (Pre-post)
deteriorated
|
2 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=54 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Bronchial Complaints (Pre-post)
improved
|
44 participants
|
|
Change of Symptom Bronchial Complaints (Pre-post)
unchanged
|
7 participants
|
|
Change of Symptom Bronchial Complaints (Pre-post)
deterioreated
|
3 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=107 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Sneezing (Pre-post)
improved
|
87 participants
|
|
Change of Symptom Sneezing (Pre-post)
unchanged
|
13 participants
|
|
Change of Symptom Sneezing (Pre-post)
deteriorated
|
7 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=102 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Rhinitis (Pre-post)
improved
|
89 participants
|
|
Change of Symptom Rhinitis (Pre-post)
unchanged
|
8 participants
|
|
Change of Symptom Rhinitis (Pre-post)
deteriorated
|
5 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=93 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symtom Fatigue / Tiredness
deteriorated
|
5 participants
|
|
Change of Symtom Fatigue / Tiredness
improved
|
77 participants
|
|
Change of Symtom Fatigue / Tiredness
unchanged
|
11 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=53 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Headache (Pre-post)
improved
|
38 participants
|
|
Change of Symptom Headache (Pre-post)
unchanged
|
15 participants
|
|
Change of Symptom Headache (Pre-post)
deteriorated
|
0 participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=82 Participants
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Change of Symptom Tearing Eyes (Pre-post)
improved
|
70 participants
|
|
Change of Symptom Tearing Eyes (Pre-post)
unchanged
|
7 participants
|
|
Change of Symptom Tearing Eyes (Pre-post)
deteriorated
|
5 participants
|
Adverse Events
PASCALLERG® Tablets in Patients With Hay Fever
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PASCALLERG® Tablets in Patients With Hay Fever
n=123 participants at risk
Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
0.81%
1/123 • Number of events 1 • 4 weeks
|
Additional Information
Jennifer Lebert
PASCOE Pharamzeutische Präparate GmbH
Phone: 0049+(0)641-7960-955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place