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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01971086
Other study ID # 40.56
Secondary ID
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


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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