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: April 9, 2014
Last verified: April 2014
  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: up to day 11 ] [ Designated as safety issue: No ]
  • 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 ]

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: up to day 11 ] [ Designated as safety issue: No ]
  • Doctors subjective assessment of overall treatment effectiveness an a 4 points rating scale at the closing/final visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]
  • Patients subjective assessment of overall treatment effectiveness an a 4 points rating scale at the closing/final visit. [ Time Frame: up to day 11 ] [ Designated as safety issue: No ]

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

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
Last Updated: April 9, 2014
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on September 16, 2014