Trial Outcomes & Findings for Phase 2 Study in Adults Sensitized to Cat (NCT NCT00689299)

Last Updated: 2014-05-01

Results Overview

Sum of individual symptoms scores, 7 items, 21 points maximum Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat. Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

167 participants

Primary outcome timeframe

20 weeks

Results posted on

2014-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.	2.1 Units Fel d 1 Active Dose Group B From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route.	0.21 Units Fel d 1 Active Dose Group A From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route.
Overall Study STARTED	58	57	54
Overall Study COMPLETED	51	54	49
Overall Study NOT COMPLETED	7	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.	2.1 Units Fel d 1 Active Dose Group B From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route.	0.21 Units Fel d 1 Active Dose Group A From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route.
Overall Study Adverse Event	2	1	1
Overall Study Lost to Follow-up	0	1	1
Overall Study Withdrawal by Subject	4	1	3
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

Phase 2 Study in Adults Sensitized to Cat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=58 Participants Placebo - Dose Group C	0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair ( n=54 Participants Active Dose Group A	2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F n=57 Participants Active Dose Group B	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	54 Participants n=7 Participants	57 Participants n=5 Participants	169 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34 years STANDARD_DEVIATION 9 • n=5 Participants	36 years STANDARD_DEVIATION 8 • n=7 Participants	33 years STANDARD_DEVIATION 9 • n=5 Participants	34.5 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	33 Participants n=7 Participants	38 Participants n=5 Participants	110 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants
Region of Enrollment United States	58 participants n=5 Participants	54 participants n=7 Participants	57 participants n=5 Participants	169 participants n=4 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: Modified Intent to Treat. All subjects with at least 1 symptom assessment during post treatment chamber exposure

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)	0.21 Units Standardized Allergenic Extract, Cat Hair n=54 Participants Dose Group A	2.1 Units Standardized Allergenic Extract, Cat Hair n=57 Participants Dose Group B
Scores on a Scale (Average of Total Symptom Scores)	7.02 Scores on a scale Standard Deviation 4.48	8.30 Scores on a scale Standard Deviation 5.14	7.87 Scores on a scale Standard Deviation 4.99

Adverse Events

Dose Group C

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Dose Group A

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Dose Group B

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Group C n=58 participants at risk placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)	Dose Group A n=54 participants at risk 0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)	Dose Group B n=57 participants at risk 2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
Nervous system disorders Severe headache	0.00% 0/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	1.9% 1/54 • Number of events 1 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	0.00% 0/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Reproductive system and breast disorders Uterine leiomyoma	0.00% 0/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	1.9% 1/54 • Number of events 1 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	0.00% 0/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.

Other adverse events

Additional Information

Mark Hites

Greer Laboratories, Inc. for Antigen Laboratories, Inc.

Phone: 828-759-7548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose Group C n=58 participants at risk placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)	Dose Group A n=54 participants at risk 0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)	Dose Group B n=57 participants at risk 2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
Respiratory, thoracic and mediastinal disorders Throat Irritation	22.4% 13/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	16.7% 9/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	28.1% 16/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Respiratory, thoracic and mediastinal disorders Sneezing	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.7% 2/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	1.8% 1/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.7% 2/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.9% 4/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	5.6% 3/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	12.3% 7/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	3.4% 2/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	7.4% 4/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Respiratory, thoracic and mediastinal disorders Cough	3.4% 2/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	5.6% 3/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Eye disorders Lacrimation increased	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	7.4% 4/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Eye disorders Eye pruritus	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	5.6% 3/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	5.3% 3/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Skin and subcutaneous tissue disorders Pruritus	13.8% 8/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	14.8% 8/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	19.3% 11/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Gastrointestinal disorders Nausea	6.9% 4/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	5.6% 3/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	12.3% 7/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Gastrointestinal disorders Abdominal pain upper	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	7.4% 4/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Gastrointestinal disorders Vomiting	1.7% 1/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	0.00% 0/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	7.0% 4/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Gastrointestinal disorders Oral pruritus	3.4% 2/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	1.9% 1/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	8.8% 5/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Gastrointestinal disorders Paraesthesia oral	5.2% 3/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.7% 2/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	3.5% 2/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.
Ear and labyrinth disorders Ear pruritus	3.4% 2/58 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	7.4% 4/54 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.	14.0% 8/57 • 20 weeks treatment plus 30 days post treatment followup. Both SAEs reported in this study occurred in the 30 day post treatment followup, and were classified as not treatment related.