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Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus in everyday curative routine treatment of acute rhinitis
Study Design:
open, observational, single-arm, uncontrolled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute rhinitis |
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| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit. | Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score. | Baseline and up to day 11 |
| The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep | The mean score of the following two "quality of life improvement" questions at the final/closing visit was calculated: "How did Rhinospray plus improve the quality of your daytime activities?" and "How did Rhinospray Plus improve the quality of your sleep?". The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4. | up to day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores. |
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Inclusion criteria:
Exclusion criteria:
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adults and children at and above 6 years old
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 40.56.36001 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||||
| 40.56.36002 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With Rhinospray Plus | Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients from the Treated Set (TS) which includes all patients who were documented to have taken at least one dose of the investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With Rhinospray Plus | Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit. | Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score. | Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint. | Posted | Median | Full Range | units on a scale | Baseline and up to day 11 |
|
up to 11 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With Rhinospray Plus | Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Baseline and up to day 11 |
| The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | The following "quality of life improvement" question at the final/closing visit were answered by the patients: "How did Rhinospray plus improve the quality of your daytime activities?" | up to 11 days |
| The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | The following "quality of life improvement" question at the final/closing visit were answered by the patients: "How did Rhinospray plus improve the quality of your sleep?" and "How did Rhinospray Plus improve the quality of your sleep?". | Up to day 11 |
| Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | The efficacy of the treatment was rated by the physician at the closing/final visit for every patient. | up to day 11 |
| Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | The efficacy of the treatment was rated by the patient at the closing/final visit. | up to day 11 |
| Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | The tolerability of the treatment was rated by the physician at the closing/final visit for every patient. | up to day 11 |
| Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | The efficacy of the treatment was rated by the patient at the closing/final visit. | up to day 11 |
| Budapest |
| Hungary |
| 40.56.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 40.56.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep | The mean score of the following two "quality of life improvement" questions at the final/closing visit was calculated: "How did Rhinospray plus improve the quality of your daytime activities?" and "How did Rhinospray Plus improve the quality of your sleep?". The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4. | Patients from FAS | Posted | Median | Full Range | units on a scale | up to day 11 |
|
|
|
| Secondary | The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores. | Patients from FAS. | Posted | Median | Full Range | units on a scale | Baseline and up to day 11 |
|
|
|
| Secondary | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | The following "quality of life improvement" question at the final/closing visit were answered by the patients: "How did Rhinospray plus improve the quality of your daytime activities?" | Patients from FAS | Posted | Number | participants | up to 11 days |
|
|
|
| Secondary | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | The following "quality of life improvement" question at the final/closing visit were answered by the patients: "How did Rhinospray plus improve the quality of your sleep?" and "How did Rhinospray Plus improve the quality of your sleep?". | Patients from FAS | Posted | Number | participants | Up to day 11 |
|
|
|
| Secondary | Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | The efficacy of the treatment was rated by the physician at the closing/final visit for every patient. | Patients from FAS. | Posted | Number | participants | up to day 11 |
|
|
|
| Secondary | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | The efficacy of the treatment was rated by the patient at the closing/final visit. | Patients from FAS | Posted | Number | participants | up to day 11 |
|
|
|
| Secondary | Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | The tolerability of the treatment was rated by the physician at the closing/final visit for every patient. | Patients from TS. | Posted | Number | participants | up to day 11 |
|
|
|
| Secondary | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | The efficacy of the treatment was rated by the patient at the closing/final visit. | Patients from TS | Posted | Number | participants | up to day 11 |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D010038 |
| Otorhinolaryngologic Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
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| No improvement |
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| Title | Measurements |
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| No improvement |
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| Measurements |
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| Poor |
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| Measurements |
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| Poor |
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| Missing |
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| Title |
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| Measurements |
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| Poor |
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| Title |
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| Measurements |
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| Poor |
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| Missing |
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