Trial Outcomes & Findings for Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine (NCT NCT00502775)
NCT ID: NCT00502775
Last Updated: 2016-12-09
Results Overview
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
COMPLETED
PHASE4
680 participants
Baseline and Weeks 1-2
2016-12-09
Participant Flow
Participant milestones
| Measure |
Placebo
|
Fluticasone Furoate 110mcg
|
Fexofenadine 180 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
229
|
224
|
227
|
|
Overall Study
COMPLETED
|
219
|
209
|
214
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
13
|
Reasons for withdrawal
| Measure |
Placebo
|
Fluticasone Furoate 110mcg
|
Fexofenadine 180 mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Sponsor Terminated Study
|
1
|
0
|
1
|
|
Overall Study
Non-compliance with eDiary
|
4
|
1
|
1
|
|
Overall Study
Subject unable to swallow capsule
|
1
|
0
|
1
|
|
Overall Study
Logpad compliance <80%
|
1
|
0
|
0
|
|
Overall Study
Randomized in error
|
0
|
1
|
1
|
|
Overall Study
Non-compliance
|
0
|
2
|
2
|
|
Overall Study
Outside pollen area more than 48 hours
|
0
|
1
|
0
|
|
Overall Study
Declining pollen counts
|
0
|
1
|
1
|
|
Overall Study
Subject in jail
|
0
|
1
|
0
|
|
Overall Study
Subject took disallowed drug
|
0
|
0
|
1
|
Baseline Characteristics
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Baseline characteristics by cohort
| Measure |
Placebo
n=229 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=227 Participants
|
Total
n=680 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.8 Years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
34.3 Years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
34.4 Years
STANDARD_DEVIATION 13.29 • n=4 Participants
|
|
Gender
Female
|
139 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
426 Participants
n=4 Participants
|
|
Gender
Male
|
90 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
181 Number of Participants
n=5 Participants
|
189 Number of Participants
n=7 Participants
|
181 Number of Participants
n=5 Participants
|
551 Number of Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
40 Number of Participants
n=5 Participants
|
29 Number of Participants
n=7 Participants
|
42 Number of Participants
n=5 Participants
|
111 Number of Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Number of Participants
n=5 Participants
|
6 Number of Participants
n=7 Participants
|
4 Number of Participants
n=5 Participants
|
18 Number of Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1-2Population: One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in the Nighttime Symptom Score (NSS)
|
-2.3 Score on a Scale
Standard Error 0.11
|
-3.1 Score on a Scale
Standard Error 0.12
|
-2.2 Score on a Scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
|
-2.9 Score on a Scale
Standard Error 0.15
|
-4.1 Score on a Scale
Standard Error 0.17
|
-2.9 Score on a Scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
|
-3.0 Score on a Scale
Standard Error 0.15
|
-4.2 Score on a Scale
Standard Error 0.18
|
-2.9 Score on a Scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
|
-2.8 Score on a Scale
Standard Error 0.14
|
-4.1 Score on a Scale
Standard Error 0.18
|
-2.8 Score on a Scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
|
-2.3 Score on a Scale
Standard Error 0.13
|
-2.7 Score on a Scale
Standard Error 0.14
|
-2.2 Score on a Scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
|
-2.5 Score on a Scale
Standard Error 0.13
|
-2.9 Score on a Scale
Standard Error 0.14
|
-2.4 Score on a Scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
|
-2.3 Score on a Scale
Standard Error 0.13
|
-2.7 Score on a Scale
Standard Error 0.14
|
-2.2 Score on a Scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
|
-2.8 Score on a Scale
Standard Error 0.15
|
-4.1 Score on a Scale
Standard Error 0.18
|
-2.7 Score on a Scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Outcome measures
| Measure |
Placebo
n=228 Participants
|
Fluticasone Furoate 110mcg
n=224 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
|
-2.2 Score on a Scale
Standard Error 0.13
|
-2.7 Score on a Scale
Standard Error 0.14
|
-2.2 Score on a Scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Population: Two subjects in the placebo group \& three in the FFNS group recorded no data during the two-week treatment period.
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Outcome measures
| Measure |
Placebo
n=226 Participants
|
Fluticasone Furoate 110mcg
n=221 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
|
4.8 Score on a Scale
Standard Error 1.27
|
13.0 Score on a Scale
Standard Error 1.61
|
2.2 Score on a Scale
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-2Population: Two subjects in the placebo group \& two in the FFNS group recorded no data during the two-week treatment period.
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Outcome measures
| Measure |
Placebo
n=226 Participants
|
Fluticasone Furoate 110mcg
n=222 Participants
|
Fexofenadine 180 mg
n=226 Participants
|
|---|---|---|---|
|
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
|
2.3 Score on a Scale
Standard Error 1.38
|
9.7 Score on a Scale
Standard Error 1.73
|
0.3 Score on a Scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: Baseline, Day 15 or if Early Withdrawal DayPopulation: Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.
Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.
Outcome measures
| Measure |
Placebo
n=218 Participants
|
Fluticasone Furoate 110mcg
n=217 Participants
|
Fexofenadine 180 mg
n=222 Participants
|
|---|---|---|---|
|
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
|
-1.4 Score on a Scale
Standard Error 0.09
|
-2.0 Score on a Scale
Standard Error 0.10
|
-1.4 Score on a Scale
Standard Error 0.10
|
Adverse Events
Placebo
Fluticasone Furoate 110mcg
Fexofenadine 180 mg
Serious adverse events
| Measure |
Placebo
n=229 participants at risk
|
Fluticasone Furoate 110mcg
n=224 participants at risk
|
Fexofenadine 180 mg
n=227 participants at risk
|
|---|---|---|---|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
Other adverse events
| Measure |
Placebo
n=229 participants at risk
|
Fluticasone Furoate 110mcg
n=224 participants at risk
|
Fexofenadine 180 mg
n=227 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.6%
6/229
|
4.5%
10/224
|
4.0%
9/227
|
|
Nervous system disorders
Sinus headache
|
0.44%
1/229
|
0.45%
1/224
|
0.44%
1/227
|
|
Nervous system disorders
Dizziness
|
0.00%
0/229
|
0.45%
1/224
|
0.44%
1/227
|
|
Nervous system disorders
Tension headache
|
0.44%
1/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Nervous system disorders
Migraine
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Nervous system disorders
Somnolence
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.44%
1/229
|
1.3%
3/224
|
1.3%
3/227
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.87%
2/229
|
0.00%
0/224
|
1.8%
4/227
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.44%
1/229
|
0.89%
2/224
|
0.88%
2/227
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/229
|
0.45%
1/224
|
0.44%
1/227
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Infections and infestations
Upper respiratory tract infection
|
0.87%
2/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Infections and infestations
Rhinitis
|
0.44%
1/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Infections and infestations
Sinusitis
|
0.44%
1/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Infections and infestations
Otitis media
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Infections and infestations
Staphylococcal infection
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Infections and infestations
Viral infection
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/229
|
0.45%
1/224
|
0.44%
1/227
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/229
|
0.45%
1/224
|
0.44%
1/227
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Gastrointestinal disorders
Oral pruritus
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/229
|
0.89%
2/224
|
0.88%
2/227
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
General disorders
Fatigue
|
0.44%
1/229
|
0.00%
0/224
|
0.44%
1/227
|
|
General disorders
Feeling jittery
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
General disorders
Ill-defined disorder
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.44%
1/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
|
Eye disorders
Conjunctivitis
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Eye disorders
Eyelid oedema
|
0.44%
1/229
|
0.00%
0/224
|
0.00%
0/227
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/229
|
0.00%
0/224
|
0.44%
1/227
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/229
|
0.45%
1/224
|
0.00%
0/227
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER