RhinitisNCT01971086

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

An observational study of Rhinitis, run by Boehringer Ingelheim at 4 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Rhinitis
How many people: 300 participants
Where: 4 sitesHungary
Study dates: Oct 2013to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: adults and children at and above 6 years old

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Hungary4 sites

40.56.36001 Boehringer Ingelheim Investigational Site
Budapest
40.56.36002 Boehringer Ingelheim Investigational Site
Budapest
40.56.36003 Boehringer Ingelheim Investigational Site
Budapest
40.56.36004 Boehringer Ingelheim Investigational Site
Budapest

Other trials in Hungary

About this study

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

Read the detailed description

Study Design:

open, observational, single-arm, uncontrolled

Conditions: Rhinitis
Medical subject headings: Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01971086
Study group	Role	What they receive
acute rhinitis		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.
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.
Measured: Baseline and up to day 11
The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep
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.
Measured: up to day 11

Secondary outcomes (7)

The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit
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.
Measured: Baseline and up to day 11
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities
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?"
Measured: up to 11 days
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep
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?".
Measured: Up to day 11
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.
The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.
Measured: up to day 11
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.
The efficacy of the treatment was rated by the patient at the closing/final visit.
Measured: up to day 11
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.
The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.
Measured: up to day 11
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.
The efficacy of the treatment was rated by the patient at the closing/final visit.
Measured: up to day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2014

First posted29 Oct 2013 (estimated)
Study startOct 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RhinitisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01971086
Sponsor's protocol ID: 40.56
Status last verified: Mar 2015
First submitted: 14 Oct 2013
Last updated: 24 Mar 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis

All Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment With Rhinospray Plus of Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary
ClinicalTrials.gov ID: NCT01971086
Acronym / sponsor ID: 40.56
Conditions: Rhinitis
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 29 Oct 2013 (estimated)
Results: Posted 24 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

open, observational, single-arm, uncontrolled

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
acute rhinitis	–	–

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: adults and children at and above 6 years old

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

7 secondary outcomes

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
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities
Time frame: up to 11 days
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep
Time frame: Up to day 11
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.
Time frame: up to day 11
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.
Time frame: up to day 11
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.
Time frame: up to day 11
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.
Time frame: up to day 11

Results and safety

Results posted to the registry on 24 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With Rhinospray Plus	300	300

Primary outcome: 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. Median (Full Range). Unit: units on a scale

Measure	Patients Treated With Rhinospray Plus n = 300
Value	-2 (-3 to 0.7)

Population analysed: Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.

Primary outcome: 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. Median (Full Range). Unit: units on a scale

Measure	Patients Treated With Rhinospray Plus n = 300
Value	1 (1 to 3)

Population analysed: Patients from FAS

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 11 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Treated With Rhinospray Plus	0 of 300 (0%)	0 of 300 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rhinitis, run by Boehringer Ingelheim at 4 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline and up to day 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.