An open clinical trial on teh efficacy of H-AL pollens (Grass mixture I) administered orally and sublingually in patients with indicated allergen immunotherapy (AIT) with Type I allergy mediated by IgE antibodies (pollens allergy), enrolled in the clinical trial according to the protocol MS01092001 - -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001521-19-CZ

Enrollment

Registered

2004-08-20

Start date

2004-09-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type I allergy to pollens mediated by IgE antibodies

Interventions

Trade Name: H-Al Pollens Smes trav I per os Product Name: H-Al pollens Smes trav I per os Pharmaceutical Form: Oral drops, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Voluntarily signed informed consent after a complete infromation of teh subject. 2.Subject, who properly finished the clinical trial according to the protocol MS01092001. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Subject, who did not properly finish the clinical trial according to the protocol MS01092001. 2.Pregnant women and women in lactation. 3.Subject unable of cooperation or irresponsible. 4.Drugs or alcohol addict. 5.Not willing to sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The evaluation of teh efficacy of standardized pollens allergens administered orally after 3-4 years lasting therapy in subjects with minimum 2 years duration of allergic disease, not treated previously by AIT (allergen immunotherapy) or treated before more than 3 years. An open continuation o 1 year double-blind placebo controlled clinical trial MS01092001 (oral and sublingual administration of allergen immunotherapy by H-Al pollens Smes trav I per os).;Secondary Objective: The evaluation of tested medicibal preparation by both routes of administration (oral and sublingual).;Primary end point(s): Efficacy. 1.Reduction of allergy symptoms evaluated by the subject during pollens allergy season. 2.Reduction of rthe frequency of rescue medication use. 3.Evaluation of skin prick tests before and after the therapy. 4.Specific IgG and IgE levels (comparison of teh avlues before and after the therapy). safety. evaluation of adverse events occurence in both groups (oral and sublingual administration) and their frequency.	—

Measure

Time frame

Main Objective: The evaluation of teh efficacy of standardized pollens allergens administered orally after 3-4 years lasting therapy in subjects with minimum 2 years duration of allergic disease, not treated previously by AIT (allergen immunotherapy) or treated before more than 3 years. An open continuation o 1 year double-blind placebo controlled clinical trial MS01092001 (oral and sublingual administration of allergen immunotherapy by H-Al pollens Smes trav I per os).;Secondary Objective: The evaluation of tested medicibal preparation by both routes of administration (oral and sublingual).;Primary end point(s): Efficacy. 1.Reduction of allergy symptoms evaluated by the subject during pollens allergy season. 2.Reduction of rthe frequency of rescue medication use. 3.Evaluation of skin prick tests before and after the therapy. 4.Specific IgG and IgE levels (comparison of teh avlues before and after the therapy). safety. evaluation of adverse events occurence in both groups (oral and sublingual administration) and their frequency.

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026