Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary

N/ACompletedNCT01971086

Boehringer Ingelheim300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Rhinitis

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (4)

40.56.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

40.56.36002 Boehringer Ingelheim Investigational Site

Budapest, Hungary

40.56.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

40.56.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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?"

Data from ClinicalTrials.gov

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