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

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

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 Overview

• Status: Completed
• Conditions: Rhinitis

Detailed Description

Study Design:

open, observational, single-arm, uncontrolled

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adults and children at and above 6 years old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
acute rhinitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: 40.56