Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen (LLB-2016-01)

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ClinicalTrials.gov Identifier: NCT02690935

Recruitment Status : Completed

First Posted : February 24, 2016

Results First Posted : December 15, 2017

Last Update Posted : September 30, 2020

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Sponsor:

Information provided by (Responsible Party):

Labo'Life

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Seasonal Allergy
Interventions	Drug: 2LALERG Drug: Placebo
Enrollment	102

Participant Flow

Recruitment Details	The first patient was enrolled in the study on 05 March 2016 and the last study visit was on 29 November 2016.
Pre-assignment Details


Arm/Group Title	2LALERG	Placebo
Arm/Group Description	Interleukin 1: 17 CH Interleukin 4:...	Non-impregnated lactose saccharose ...
Arm/Group Description	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	Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Period Title: Overall Study
Started	51 ^[1]	51 ^[1]
Completed	51 ^[1]	51 ^[1]
Not Completed	0	0
[1] Count of participants

Baseline Characteristics

Arm/Group Title		2LALERG	Placebo	Total
Arm/Group Description		Interleukin 1: 17 CH Interleukin 4:...	Non-impregnated lactose saccharose ...	Total of all reporting groups
Arm/Group Description		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	Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo	Total of all reporting groups
Overall Number of Baseline Participants		51	51	102
Baseline Analysis Population Description		...
Baseline Analysis Population Description		No difference
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	51 participants	51 participants	102 participants
		39.5 (14.5)	40.7 (15.1)	40.1 (14.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	51 participants	51 participants	102 participants
	Female	23 45.1%	26 51.0%	49 48.0%
	Male	28 54.9%	25 49.0%	53 52.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	51 participants	51 participants	102 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	51 100.0%	51 100.0%	102 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Belgium	Number Analyzed	51 participants	51 participants	102 participants
Belgium		51	51	102

Outcome Measures

1.Primary Outcome


Title	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)
Description	Area under the curve [AUC] (total score of symptoms taking into accoun...
Description	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.
Time Frame	Up to Month 6 (end of pollen season)

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	2LALERG	Placebo
Arm/Group Description:	Interleukin 1: 17 CH Interleukin 4:...	Non-impregnated lactose saccharose ...
Arm/Group Description:	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	Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Overall Number of Participants Analyzed	49	47
Mean (Standard Deviation) Unit of Measure: T5SS score corrected with RM * day
	2.76 (1.89)	2.97 (2.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2LALERG, Placebo
	Comments	H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.642
	Comments	No adjustment of the p-value
	Method	t-test, 2 sided
	Comments	[Not Specified]

2.Secondary Outcome


Title	Quality of Life During the Whole Period of Observation
Description	This is the mean of the score to 3 daily quality of life questions: 1)...
Description	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.
Time Frame	QoL scores were assessed daily for up to 6 months

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	2LALERG	Placebo
Arm/Group Description:	Interleukin 1: 17 CH Interleukin 4:...	Non-impregnated lactose saccharose ...
Arm/Group Description:	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	Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
Overall Number of Participants Analyzed	49	47
Mean (Standard Deviation) Unit of Measure: units on a scale
	0.84 (0.88)	0.81 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2LALERG, Placebo
	Comments	H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.829
	Comments	No adjustment for multiplicity
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	2LALERG		Placebo
Arm/Group Description	Interleukin 1: 17 CH Interleukin 4:...		Non-impregnated lactose saccharose ...
Arm/Group Description	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		Non-impregnated lactose saccharose globules (380 mg/capsule) Placebo: Placebo
All-Cause Mortality
	2LALERG		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/51 (0.00%)		0/51 (0.00%)
Serious Adverse Events Serious Adverse Events
	2LALERG		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/51 (1.96%)		2/51 (3.92%)
Cardiac disorders
Atrial fibrillation ^* 1	0/51 (0.00%)	0	1/51 (1.96%)	1
Nervous system disorders
Transient ischemic attack ^* 1	0/51 (0.00%)	0	1/51 (1.96%)	1
Psychiatric disorders
Cocaine abuse ^* 1	1/51 (1.96%)	1	0/51 (0.00%)	0
Renal and urinary disorders
Nephrolithiasis ^* 1	0/51 (0.00%)	0	1/51 (1.96%)	1
1 Term from vocabulary, MedDRA (10.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	2LALERG		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/51 (13.73%)		7/51 (13.73%)
Gastrointestinal disorders
Enteritis ^* 1	3/51 (5.88%)	3	1/51 (1.96%)	1
Infections and infestations
Bronchitis ^* 1	3/51 (5.88%)	3	0/51 (0.00%)	0
Rhinitis ^* 1	1/51 (1.96%)	1	3/51 (5.88%)	3
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	0/51 (0.00%)	0	3/51 (5.88%)	3
1 Term from vocabulary, MedDRA (10.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

Allergy cases were mainly prevalent and chronic.
Many concomitant drugs were taken
Patients were older in this trial compared to Van der Brempt et al. (2011)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Stephane Heijmans
Organization:	ECSOR
Phone:	3267444093
EMail:	Jacques.Bruhwyler@ecsor.com

Layout table for additonal information

Responsible Party:	Labo'Life
ClinicalTrials.gov Identifier:	NCT02690935
Other Study ID Numbers:	LLB-2016-01
First Submitted:	February 17, 2016
First Posted:	February 24, 2016
Results First Submitted:	April 7, 2017
Results First Posted:	December 15, 2017
Last Update Posted:	September 30, 2020

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