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

NCT01971086 | Completed Results

• 1 other identifier: 40.56
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities

  up to 11 days

• The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep

  Up to day 11

• Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.

  up to day 11

• Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.

  up to day 11

Study Arms (1)

acute rhinitis

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults and children at and above 6 years old

You may qualify if:

• Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent
• Male and female ambulatory outpatients being seen in a participating physicians office for routine care
• Patients with a clinical diagnosis of Rhinitis acuta
• Patient having the cognitive and functional abilities for answering the symptom specific questions
• Patients having expressed the willingness to participate in this observational study
• Patients at and above the age of 6
• Rhinospray Plus naive patients (patients who have not used Rhinospray Plus before)

You may not qualify if:

• Uncooperative patients based on physicians judgement
• Patients with any conditions making the application of Rhinospray plus contraindicated
• Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems
• Withdraw of Informed Consent
• Pregnancy or breast-feeding as stated in the Summary of Product Characteristic (SmPC)
• Patients with clinical diagnosis of allergic rhinitis

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

40.56.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

40.56.36002 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

40.56.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

40.56.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 24, 2015
• Results First Posted: March 24, 2015

Record last verified: 2015-03

Locations

HU (4)