Trial Outcomes & Findings for Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen (NCT NCT02690935)

Results Overview

Area under the curve \[AUC\] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

102 participants

Primary outcome timeframe

Up to Month 6 (end of pollen season)

Results posted on

2020-09-30

Participant Flow

The first patient was enrolled in the study on 05 March 2016 and the last study visit was on 29 November 2016.

Participant milestones

Participant milestones
Measure	2LALERG Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Overall Study STARTED	51	51
Overall Study COMPLETED	51	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2LALERG n=51 Participants Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo n=51 Participants Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo	Total n=102 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 14.5 • n=5 Participants	40.7 years STANDARD_DEVIATION 15.1 • n=7 Participants	40.1 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	51 participants n=5 Participants	51 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Month 6 (end of pollen season)

Population: ITT population

Area under the curve \[AUC\] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.

Outcome measures

Outcome measures
Measure	2LALERG n=49 Participants Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo n=47 Participants Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)	2.76 T5SS score corrected with RM * day Standard Deviation 1.89	2.97 T5SS score corrected with RM * day Standard Deviation 2.48

SECONDARY outcome

Timeframe: QoL scores were assessed daily for up to 6 months

Population: ITT population

This is the mean of the score to 3 daily quality of life questions: 1) Did you sleep well (0 to 3), 2) Are you able to work (0 to 3), 3) How do you feel today (0 to 3). The minimum daily score is 0 (good quality of life) and the maximum is 9 (bad quality of life). The mean of the daily scores was calculated over the whole period of observation (up to 6 months) for each patient.

Outcome measures

Outcome measures
Measure	2LALERG n=49 Participants Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo n=47 Participants Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Quality of Life During the Whole Period of Observation	0.84 units on a scale Standard Deviation 0.88	0.81 units on a scale Standard Deviation 0.81

Adverse Events

2LALERG

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2LALERG n=51 participants at risk Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo n=51 participants at risk Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Psychiatric disorders Cocaine abuse	2.0% 1/51 • Number of events 1 • 6 months	0.00% 0/51 • 6 months
Cardiac disorders Atrial fibrillation	0.00% 0/51 • 6 months	2.0% 1/51 • Number of events 1 • 6 months
Nervous system disorders Transient ischemic attack	0.00% 0/51 • 6 months	2.0% 1/51 • Number of events 1 • 6 months
Renal and urinary disorders Nephrolithiasis	0.00% 0/51 • 6 months	2.0% 1/51 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	2LALERG n=51 participants at risk Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH Impregnated on lactose saccharose globules (380 mg/capsule) 2LALERG: Homeopathic drug	Placebo n=51 participants at risk Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Gastrointestinal disorders Enteritis	5.9% 3/51 • Number of events 3 • 6 months	2.0% 1/51 • Number of events 1 • 6 months
Infections and infestations Bronchitis	5.9% 3/51 • Number of events 3 • 6 months	0.00% 0/51 • 6 months
Infections and infestations Rhinitis	2.0% 1/51 • Number of events 1 • 6 months	5.9% 3/51 • Number of events 3 • 6 months
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/51 • 6 months	5.9% 3/51 • Number of events 3 • 6 months

Additional Information

Dr. Stephane Heijmans

ECSOR

Phone: 3267444093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60