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

NCT ID: NCT01971086

Last Updated: 2015-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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Study Design:

open, observational, single-arm, uncontrolled

Conditions

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Rhinitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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acute rhinitis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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40.56.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

40.56.36002 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

40.56.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

40.56.36004 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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40.56

Identifier Type: -

Identifier Source: org_study_id

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