Trial Outcomes & Findings for Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis (NCT NCT02288156)
NCT ID: NCT02288156
Last Updated: 2021-06-22
Results Overview
patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Baseline and week 4
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
0,1mM
Capsaicin: via nasal spray
|
0,01mM
Capsaicin: via nasal spray
|
0.001mM
Capsaicin: via nasal spray
|
Placebo
placebo: via nasal spray
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
16
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50 Years
STANDARD_DEVIATION 14 • n=16 Participants
|
45 Years
STANDARD_DEVIATION 10 • n=16 Participants
|
48 Years
STANDARD_DEVIATION 14 • n=18 Participants
|
45 Years
STANDARD_DEVIATION 15 • n=18 Participants
|
47 Years
STANDARD_DEVIATION 13 • n=68 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=16 Participants
|
7 Participants
n=16 Participants
|
9 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
35 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
9 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
33 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline and week 4patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Change in Visual Analogue Scale for Major Nasal Symptoms
Week 4
|
3.66 score on a scale
Standard Deviation 2.78
|
4.29 score on a scale
Standard Deviation 2.92
|
4.49 score on a scale
Standard Deviation 2.93
|
5.6 score on a scale
Standard Deviation 1.67
|
|
Change in Visual Analogue Scale for Major Nasal Symptoms
Baseline
|
8.36 score on a scale
Standard Deviation 1.68
|
8.03 score on a scale
Standard Deviation 1.36
|
7.74 score on a scale
Standard Deviation 1.48
|
8.24 score on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline, week 4patients score all kinds of nasal symptoms from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Change in Visual Analogue Scale for Individual Nasal Symptoms
Rhinorrhea Baseline
|
7.594 score on a scale
Standard Deviation 2.569
|
5.994 score on a scale
Standard Deviation 3.305
|
4.212 score on a scale
Standard Deviation 3.318
|
5.806 score on a scale
Standard Deviation 3.751
|
|
Change in Visual Analogue Scale for Individual Nasal Symptoms
Rhinorrhea Week 4
|
2.738 score on a scale
Standard Deviation 2.796
|
2.313 score on a scale
Standard Deviation 2.572
|
2.383 score on a scale
Standard Deviation 2.868
|
3.018 score on a scale
Standard Deviation 2.325
|
SECONDARY outcome
Timeframe: week 4Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms).
Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Therapeutic Response in All Treatment Regimes
|
70 percentage of patients with improvement
|
82 percentage of patients with improvement
|
35 percentage of patients with improvement
|
23 percentage of patients with improvement
|
SECONDARY outcome
Timeframe: baseline, week 4change in the number of participants with nasal hyperreactivity in all treatment modalities
Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Change of Nasal Hyperreactivity in All Treatment Modalities.
Baseline
|
7 participants
|
9 participants
|
8 participants
|
9 participants
|
|
Change of Nasal Hyperreactivity in All Treatment Modalities.
week 4
|
5 participants
|
5 participants
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: week 4Population: All reported AEs were entered into the AE section so please see AE section for specifics.
All reported AEs were entered into the AE section so please see AE table for specifics.
Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Number of Adverse Events in All Treatment Groups
|
27 Total number of events
|
24 Total number of events
|
32 Total number of events
|
29 Total number of events
|
SECONDARY outcome
Timeframe: week 4, 12 and 26Outcome measures
| Measure |
0,1mM
n=16 Participants
Capsaicin: via nasal spray
|
0,01mM
n=16 Participants
Capsaicin: via nasal spray
|
0.001mM
n=18 Participants
Capsaicin: via nasal spray
|
Placebo
n=18 Participants
placebo: via nasal spray
|
|---|---|---|---|---|
|
Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities
|
10 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
Adverse Events
0,1mM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0,01mM
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.001mM
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0,1mM
n=16 participants at risk
Capsaicin: via nasal spray
|
0,01mM
n=16 participants at risk
Capsaicin: via nasal spray
|
0.001mM
n=18 participants at risk
Capsaicin: via nasal spray
|
Placebo
n=18 participants at risk
placebo: via nasal spray
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Ear Infection
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Eye infection
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Eye disorders
Eye Pruritus
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Surgical and medical procedures
Eyelid operation
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Food poisoning
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
5.6%
1/18 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
16.7%
3/18 • Number of events 3 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Laryngitis
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
6.2%
1/16 • Number of events 2 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
General disorders
Malaise
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Immune system disorders
Mite allergy
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • 12 weeks
|
18.8%
3/16 • Number of events 3 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Infections and infestations
nasopharyngitis
|
43.8%
7/16 • Number of events 11 • 12 weeks
|
31.2%
5/16 • Number of events 9 • 12 weeks
|
44.4%
8/18 • Number of events 9 • 12 weeks
|
33.3%
6/18 • Number of events 9 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 2 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/16 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/16 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 2 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
16.7%
3/18 • Number of events 5 • 12 weeks
|
11.1%
2/18 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16 • 12 weeks
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat clearing
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Infections and infestations
Tonsilitis
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • 12 weeks
|
0.00%
0/16 • 12 weeks
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place