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

Completed

• Conditions: Rhinitis

• Registration Number: NCT01971086
• Lead Sponsor: Boehringer Ingelheim

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Results First Submitted: 2015-03-13
• Results First Submitted QC: 2015-03-13
• Last Update Submitted: 2015-03-13
• Results First Posted: 2015-03-24
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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?"
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.
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.
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?".

Trial Locations

Locations (4)

40.56.36002 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

40.56.36003 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

40.56.36001 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

40.56.36004 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary