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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01971086
First received: October 14, 2013
Last updated: March 13, 2015
Last verified: March 2015
  Purpose

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


Condition
Rhinitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Treatment With Rhinospray Plus of Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit. [ Time Frame: Baseline and up to day 11 ] [ Designated as safety issue: No ]
    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.

  • The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit [ Time Frame: Baseline and up to day 11 ] [ Designated as safety issue: No ]
    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 Daytime Activities [ Time Frame: up to 11 days ] [ Designated as safety issue: No ]
    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?"

  • The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep [ Time Frame: Up to day 11 ] [ Designated as safety issue: No ]
    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?".

  • Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
    The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.

  • Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
    The efficacy of the treatment was rated by the patient at the closing/final visit.

  • Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
    The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.

  • Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
    The efficacy of the treatment was rated by the patient at the closing/final visit.


Enrollment: 300
Study Start Date: October 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute rhinitis

Detailed Description:

Study Design:

open, observational, single-arm, uncontrolled

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adults and children at and above 6 years old

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971086

Locations
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, Hungary
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01971086     History of Changes
Other Study ID Numbers: 40.56
Study First Received: October 14, 2013
Results First Received: March 13, 2015
Last Updated: March 13, 2015
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Common Cold
Rhinitis
Nose Diseases
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2015