Rhinitis
Conditions
Brief summary
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
Detailed description
Study Design: open, observational, single-arm, uncontrolled
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent 2. Male and female ambulatory outpatients being seen in a participating physicians office for routine care 3. Patients with a clinical diagnosis of Rhinitis acuta 4. Patient having the cognitive and functional abilities for answering the symptom specific questions 5. Patients having expressed the willingness to participate in this observational study 6. Patients at and above the age of 6 7. Rhinospray Plus naive patients (patients who have not used Rhinospray Plus before)
Exclusion criteria
1. Uncooperative patients based on physicians judgement 2. Patients with any conditions making the application of Rhinospray plus contraindicated 3. Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems 4. Withdraw of Informed Consent 5. Pregnancy or breast-feeding as stated in the Summary of Product Characteristic (SmPC) 6. Patients with clinical diagnosis of allergic rhinitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit. | Baseline and up to day 11 | 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. |
| The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep | up to day 11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | Up to day 11 | 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?. |
| Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | up to day 11 | The efficacy of the treatment was rated by the physician at the closing/final visit for every patient. |
| The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Baseline and up to day 11 | 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. |
| Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | up to day 11 | The tolerability of the treatment was rated by the physician at the closing/final visit for every patient. |
| Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | up to day 11 | The efficacy of the treatment was rated by the patient at the closing/final visit. |
| Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | up to day 11 | The efficacy of the treatment was rated by the patient at the closing/final visit. |
| The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | up to 11 days | 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? |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | Patients Treated With Rhinospray Plus |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 20 |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 |
Outcome results
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.
Time frame: Baseline and up to day 11
Population: Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Rhinospray Plus | The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit. | -2 units on a scale |
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.
Time frame: up to day 11
Population: Patients from FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Rhinospray Plus | The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep | 1 units on a scale |
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.
Time frame: up to day 11
Population: Patients from FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | Very good | 212 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | Good | 74 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | Fair | 12 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | Poor | 1 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. | Missing | 1 participants |
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.
Time frame: up to day 11
Population: Patients from TS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | Very good | 230 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | Good | 62 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | Fair | 7 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | Poor | 0 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. | Missing | 1 participants |
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.
Time frame: up to day 11
Population: Patients from FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | Very good | 222 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | Good | 70 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | Fair | 8 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. | Poor | 0 participants |
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.
Time frame: up to day 11
Population: Patients from TS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | Very good | 236 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | Good | 64 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | Fair | 0 participants |
| Patients Treated With Rhinospray Plus | Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. | Poor | 0 participants |
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.
Time frame: Baseline and up to day 11
Population: Patients from FAS.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Running Nose | -2 units on a scale |
| Patients Treated With Rhinospray Plus | The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Blocked Nose | -3 units on a scale |
| Patients Treated With Rhinospray Plus | The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit | Sneezing | -1 units on a scale |
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?
Time frame: up to 11 days
Population: Patients from FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | Strongly | 231 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | Moderately | 61 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | Weakly | 8 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities | No improvement | 0 participants |
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?.
Time frame: Up to day 11
Population: Patients from FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | Strongly | 236 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | Moderately | 51 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | Weakly | 5 participants |
| Patients Treated With Rhinospray Plus | The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep | No improvement | 8 participants |