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Completed

NCT Number: NCT01971086

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

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

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

40.56.36001 Boehringer Ingelheim Investigational Site, Budapest, Hungary

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About this study

Study Design:

open, observational, single-arm, uncontrolled

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

    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 outcomes

  1. 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

    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.

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

    Time frame: up to 11 days

    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?"

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

    Time frame: Up to day 11

    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?".

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

    Time frame: up to day 11

    The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.

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

    Time frame: up to day 11

    The efficacy of the treatment was rated by the patient at the closing/final visit.

  6. Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.

    Time frame: up to day 11

    The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.

  7. Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.

    Time frame: up to day 11

    The efficacy of the treatment was rated by the patient at the closing/final visit.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2013
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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