Trial Outcomes & Findings for Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy (NCT NCT01777438)
NCT ID: NCT01777438
Last Updated: 2013-12-17
Results Overview
Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)
COMPLETED
434 participants
3 years after starting SCIT
2013-12-17
Participant Flow
Participant milestones
| Measure |
Control Group
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
|---|---|---|
|
Overall Study
STARTED
|
352
|
82
|
|
Overall Study
COMPLETED
|
352
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Baseline characteristics by cohort
| Measure |
Control Group
n=352 Participants
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
n=82 Participants
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
Total
n=434 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
352 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
434 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
185 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
352 participants
n=93 Participants
|
82 participants
n=4 Participants
|
434 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 years after starting SCITPercentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)
Outcome measures
| Measure |
Control Group
n=352 Participants
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
n=82 Participants
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
|---|---|---|
|
Current Medication Use Three Years After Diagnosis of AR
|
61 percentage of participants
|
29 percentage of participants
|
PRIMARY outcome
Timeframe: 3 years after diagnosisVisual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.
Outcome measures
| Measure |
Control Group
n=353 Participants
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
n=81 Participants
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
|---|---|---|
|
Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.
|
3.7 Score on a scale
Standard Deviation 2.8
|
2.5 Score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 3 years after starting SCITBased on the proposed cut-off value of VAS \< 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients
Outcome measures
| Measure |
Control Group
n=352 Participants
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
n=82 Participants
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
|---|---|---|
|
Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment
|
63 percentage of participants
|
84 percentage of participants
|
SECONDARY outcome
Timeframe: 3 years after diagnosisARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis. Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR
Outcome measures
| Measure |
Control Group
n=353 Participants
a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
|
Patients Having SCIT
n=81 Participants
patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
|
|---|---|---|
|
Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis
|
32 percentage of participants
|
78 percentage of participants
|
Adverse Events
Control Group
Patients Having SCIT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place