N/A
N=300
Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary
Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01971086 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: 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. — -2 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-2 | — |
| PRIMARY The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep |
1 | — |
| SECONDARY The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit |
-3; -1; -2 | — |
| SECONDARY The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities |
231; 61; 8; 0 | — |
| SECONDARY The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep |
236; 51; 5; 8 | — |
| SECONDARY Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. |
222; 70; 8; 0 | — |
| SECONDARY Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. |
212; 74; 12; 1; 1 | — |
| SECONDARY Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. |
236; 64; 0; 0 | — |
| SECONDARY Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. |
230; 62; 7; 0; 1 | — |
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
Eligibility Criteria
Inclusion criteria
- Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent
- Male and female ambulatory outpatients being seen in a participating physicians office for routine care
- Patients with a clinical diagnosis of Rhinitis acuta
- Patient having the cognitive and functional abilities for answering the symptom specific questions
- Patients having expressed the willingness to participate in this observational study
- Patients at and above the age of 6
- Rhinospray Plus naive patients (patients who have not used Rhinospray Plus before)
Exclusion criteria
- Uncooperative patients based on physicians judgement
- Patients with any conditions making the application of Rhinospray plus contraindicated
- Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems
- Withdraw of Informed Consent
- Pregnancy or breast-feeding as stated in the Summary of Product Characteristic (SmPC)
- Patients with clinical diagnosis of allergic rhinitis
Data sourced from ClinicalTrials.gov (NCT01971086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.