A Phase 4 interventional study of 2LALERG and Placebo in Seasonal Allergy, sponsored by Labo'Life. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by Labo'Life · Phase 4, Interventional, and Treatment
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to rescue medication intake. The secondary objectives are to compare the allergy symptoms, the rescue medication intake, the quality of life and the safety in patients treated with 2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two months before traditional pollen peak, then visits at 3 months and 6 months, or end of the peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant treatments are the already established treatments for associated pathologies not liable to have an impact on the proper conduct of the study and the rescue medications allowed in the first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those above]).
The prohibited treatments are the oral or injectable corticosteroids and the anti-leukotrienes.
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to rescue medication intake. The secondary objectives are to compare the allergy symptoms, the rescue medication intake, the quality of life and the safety in patients treated with 2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two months before traditional pollen peak, then visits at 3 months and 6 months, or end of the peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant treatments are the already established treatments for associated pathologies not liable to have an impact on the proper conduct of the study and the rescue medications allowed in the first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those above]).
The prohibited treatments are the oral or injectable corticosteroids and the anti-leukotrienes.
The following demographic data will be collected during the first visit: date of birth, gender, ethnic group, weight, height, smoking habits and alcohol use status.
Medical history, treatment history, concomitant treatments and patient's physical examination will also be documented during V0.
The allergy must be confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE are positive if at least class 3 (≥ 3.5 kU / L); these tests must have been made at the latest during the first visit.
A patient diary will be given to each patient:
This patient diary will be given to the patient at each visit, and will be brought back at the next visit, it will be reviewed and validated by the investigator and will be part of the Case Report Form.
All relevant (related to allergy) concomitant medications taken by the patient during the study period will be recorded at each visit in the CRF.
The AEs and SAEs will be recorded at V1 and V2 in order to assess safety.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's enrollment of 102 is below the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Labo'Life is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: 2LALERG
Non-impregnated lactose saccharose globules (380 mg/capsule)
Drug: Placebo
Homeopathic drug
Also known as: Immunotherapy
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)
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)
Quality of Life During the Whole Period of Observation
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
The first patient was enrolled in the study on 05 March 2016 and the last study visit was on 29 November 2016.
| Milestone | 2LALERG | Placebo |
|---|---|---|
| Started | 51 | 51 |
| Completed | 51 | 51 |
| Not completed | 0 | 0 |
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.
| T5SS score corrected with RM * day | 2LALERG | 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 ± 1.89 | 2.97 ± 2.48 |
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.
| units on a scale | 2LALERG | Placebo |
|---|---|---|
| Quality of Life During the Whole Period of Observation | 0.84 ± 0.88 | 0.81 ± 0.81 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2LALERG | 0/51 (0%) | 1/51 (2%) | 7/51 (13.7%) |
| Placebo | 0/51 (0%) | 2/51 (3.9%) | 7/51 (13.7%) |
| Event | 2LALERG | Placebo |
|---|---|---|
| Cocaine abusePsychiatric disorders | 1/51 | 0/51 |
| Atrial fibrillationCardiac disorders | 0/51 | 1/51 |
| Transient ischemic attackNervous system disorders | 0/51 | 1/51 |
| NephrolithiasisRenal and urinary disorders | 0/51 | 1/51 |
| Event | 2LALERG | Placebo |
|---|---|---|
| EnteritisGastrointestinal disorders | 3/51 | 1/51 |
| BronchitisInfections and infestations | 3/51 | 0/51 |
| RhinitisInfections and infestations | 1/51 | 3/51 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/51 | 3/51 |
No difference
| Age, Continuous(years) | 2LALERG | Placebo | Total |
|---|---|---|---|
| Mean | 39.5 ± 14.5 | 40.7 ± 15.1 | 40.1 ± 14.8 |
| Sex: Female, Male(Participants) | 2LALERG | Placebo | Total |
|---|---|---|---|
| Female | 23 | 26 | 49 |
| Male | 28 | 25 | 53 |
| Ethnicity (NIH/OMB)(Participants) | 2LALERG | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 51 | 51 | 102 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 2LALERG | Placebo | Total |
|---|---|---|---|
| Belgium | 51 | 51 | 102 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Mar 2016, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2017, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Rhinitis, Allergic, Seasonal →
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