NCT02295969

Brief Summary

Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

November 18, 2014

Last Update Submit

July 25, 2017

Conditions

Allergy

Keywords

RhinitisConjunctivitisGrass pollenSublingual tabletAllergen immunotherapySafety

Outcome Measures

Primary Outcomes (1)

  • All adverse events that started on or after the day the first dose of Oralair

    During 30 days after the date of the first dose

Interventions

OralairDRUG

Observational study, Oralair is used as prescribed by the prescriber phycisian.

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.

You may qualify if:

  • Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.

You may not qualify if:

  • Patients already participating in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Augsburg, Klinik für Kinder und Jugendliche

Augsburg, Bavaria, 86156, Germany

Location

Related Publications (1)

  • Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.

    PMID: 31009701DERIVED

MeSH Terms

Conditions

HypersensitivityRhinitisConjunctivitis

Interventions

Sweet Vernal, orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract

Condition Hierarchy (Ancestors)

Immune System DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesConjunctival DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

December 1, 2014

Primary Completion

July 3, 2017

Study Completion

July 3, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

DE(1)