Trial Outcomes & Findings for Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary (NCT NCT01971086)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

Baseline and up to day 11

Results posted on

2015-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Treated With Rhinospray Plus Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Age, Continuous	27.7 years STANDARD_DEVIATION 20.0 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to day 11

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

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.

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.	-2 units on a scale Interval -3.0 to 0.7

PRIMARY outcome

Timeframe: up to day 11

Population: Patients from FAS

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.

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep	1 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and up to day 11

Population: Patients from FAS.

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.

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit Blocked Nose	-3 units on a scale Interval -3.0 to 1.0
The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit Sneezing	-1 units on a scale Interval -3.0 to 2.0
The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit Running Nose	-2 units on a scale Interval -3.0 to 1.0

SECONDARY outcome

Timeframe: up to 11 days

Population: Patients from FAS

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?"

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities Strongly	231 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities Moderately	61 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities Weakly	8 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities No improvement	0 participants

SECONDARY outcome

Timeframe: Up to day 11

Population: Patients from FAS

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?".

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep Strongly	236 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep Moderately	51 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep Weakly	5 participants
The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep No improvement	8 participants

SECONDARY outcome

Timeframe: up to day 11

Population: Patients from FAS.

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

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. Very good	222 participants
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. Good	70 participants
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. Fair	8 participants
Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit. Poor	0 participants

SECONDARY outcome

Timeframe: up to day 11

Population: Patients from FAS

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

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. Missing	1 participants
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. Very good	212 participants
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. Good	74 participants
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. Fair	12 participants
Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit. Poor	1 participants

SECONDARY outcome

Timeframe: up to day 11

Population: Patients from TS.

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

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. Very good	236 participants
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. Good	64 participants
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. Fair	0 participants
Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit. Poor	0 participants

SECONDARY outcome

Timeframe: up to day 11

Population: Patients from TS

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

Outcome measures

Outcome measures
Measure	Patients Treated With Rhinospray Plus n=300 Participants Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. Very good	230 participants
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. Good	62 participants
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. Fair	7 participants
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. Poor	0 participants
Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit. Missing	1 participants

Adverse Events

Patients Treated With Rhinospray Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER