Clinical trial NCT01971086: Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary
Official title: Treatment With Rhinospray Plus of Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-29
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults and children at and above 6 years old

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

Detailed description: Study Design:

open, observational, single-arm, uncontrolled

Eligibility 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

Primary outcomes:
measure: The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.
timeFrame: Baseline and up to day 11
measure: The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep
timeFrame: up to day 11
Secondary outcomes:
measure: The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit
timeFrame: Baseline and up to day 11
measure: The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities
timeFrame: up to 11 days
measure: The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep
timeFrame: Up to day 11
measure: Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.
timeFrame: up to day 11
measure: Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.
timeFrame: up to day 11
measure: Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.
timeFrame: up to day 11
measure: Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.
timeFrame: up to day 11
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: 40.56.36001 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 40.56.36002 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 40.56.36003 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 40.56.36004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: