NCT02126111

Brief Summary

The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

5.5 years

First QC Date

February 12, 2014

Last Update Submit

November 5, 2016

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Symptoms and medication scores comparison between active and placebo group

    Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).

    two years

Secondary Outcomes (10)

  • Response to nasal allergen provocation test with phleum (NAPT-Phl)

    two years

  • Skin prick-test (SPT) with phleum.

    2 years

  • Intradermal test (IDT) with phleum

    2 years

  • FEV1

    2 years

  • Quality of life questionnaire RQLQ

    2 years

  • +5 more secondary outcomes

Study Arms (2)

DEPIGOID phleum

ACTIVE COMPARATOR

The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.

Biological: DEPIGOID phleum

DEPIGOID Placebo & DEPIGOID Phleum

PLACEBO COMPARATOR

This arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study. DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract.

Biological: DEPIGOID phleumBiological: DEPIGOID Placebo

Interventions

DEPIGOID phleumBIOLOGICAL

Subcutaneous Immunotherapy with modified extract of Phleum pollen.

DEPIGOID Placebo & DEPIGOID PhleumDEPIGOID phleum
DEPIGOID PlaceboBIOLOGICAL

Placebo for subcutaneous administration

DEPIGOID Placebo & DEPIGOID Phleum

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Local allergic rhinitis with sensitization to grass pollen
  • Skin prick test and serum specific IgE negative to grass pollen.
  • Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
  • Written informed consent

You may not qualify if:

  • Immunological diseases
  • Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
  • Treatment with beta-blockers
  • Severe psychological disorders
  • Severe atopic dermatitis
  • FEV1 \< 70% of reference value after treatment
  • Hypersensitivity or intolerance to excipients and / or medication trial.
  • Failure to adequately perform diagnostic tests or treatment.
  • Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response.
  • Pregnant women or at risk of pregnancy and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Infanta Leonor

Madrid, Madrid, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, Malaga, Spain

Location

Related Publications (1)

  • Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.

    PMID: 29168570DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Miguel Blanca, MD, PhD

    Hospital Regional Universitario, Málaga, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Allergy Unit

Study Record Dates

First Submitted

February 12, 2014

First Posted

April 29, 2014

Study Start

October 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)