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

Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971086
• Other study ID #: 40.56
• Status: Completed
• Phase: N/A
• First received: October 14, 2013
• Last updated: March 13, 2015
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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

Description:

Study Design:

open, observational, single-arm, uncontrolled

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Common Cold
• Rhinitis

Locations

Country	Name	City	State
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	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and up to day 11	No
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.	up to day 11	No
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.	Baseline and up to day 11	No
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?"	up to 11 days	No
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?".	Up to day 11	No
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.	up to day 11	No
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.	up to day 11	No
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.	up to day 11	No
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.	up to day 11	No

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