Observational study in allergic patients to treating hay fever against grass pollen. Patient reported outcome in patients treated with various doses of Depigoid Phleum.

Non-interventional Study in Allergic Patients Suffering from Grass Pollen Induced Rhinitis/Rhinoconjunctivitis with or without Asthma. Retrospective Assessment of the Efficacy of a Perennial Specific Immunotherapy on the Allergy Symptoms / Disease Activity during the Pollen Season - Depigoid Phleum - PRO 2013

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004920-12-CZ

Enrollment

275

Registered

2013-12-11

Start date

2014-02-12

Completion date

Unknown

Last updated

2016-11-28

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

Conditions

Allergic rhinitis/rhinoconjunctivitis with or without concomitant asthma due to grass pollen allergy MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 MedDRA version: 14.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855

Interventions

Product Name: Depigoid® Phleum 100 DPP/ml Product Code: Depigoid® Phleum Pharmaceutical Form: Suspension for injection INN or Proposed INN: Modified allergen extract of Phleum pratense Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Written informed consent · Allergic rhinitis/rhinoconjunctivitis with or without concomitant asthma due to grass pollen allergy · Treatment with one of 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) in the period from October 2012 until April 2013. Are the trial subjects under 18? no 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 266 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9

Exclusion criteria

Exclusion criteria: · Less than 4 applications of 0,5 ml of one of 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) between October 2012 and April 2013

Design outcomes

Primary

Measure	Time frame
Main Objective: · Patient Reported Outcome (PRO) of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the Symptom and Rescue Medication Score (SMS). · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the VAS for disease activity. · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the allergy symptoms during the grass pollen season 2013 by means of the symptom score (SS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the intake of rescue medication during the grass pollen season 2013 by means of the rescue medication score (RMS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum during the grass pollen season 2013 by means of global assessment.;Secondary Objective: Not applicable;Primary end point(s): - the symptom and rescue medication score (SMS) - the symptom score (SS) - the rescue medication score (RMS) - the VAS for disease activity - the global assessment;Timepoint(s) of evaluation of this end point: Period for collection of data: OCT – DEC 2013	—

Measure

Time frame

Main Objective: · Patient Reported Outcome (PRO) of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the Symptom and Rescue Medication Score (SMS). · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum by means of the VAS for disease activity. · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the allergy symptoms during the grass pollen season 2013 by means of the symptom score (SS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum on the intake of rescue medication during the grass pollen season 2013 by means of the rescue medication score (RMS) · PRO of 5-6 months of pre-seasonal therapy with Depigoid Phleum during the grass pollen season 2013 by means of global assessment.;Secondary Objective: Not applicable;Primary end point(s): - the symptom and rescue medication score (SMS) - the symptom score (SS) - the rescue medication score (RMS) - the VAS for disease activity - the global assessment;Timepoint(s) of evaluation of this end point: Period for collection of data: OCT – DEC 2013

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Czech Republic

Contacts

Public ContactMedical Department

LETI Pharma GmbH

info@leti.de00492302202860

Outcome results

None listed

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