NCT01740284 (GT-19) is a Phase 3 clinical trial of Grazax + Aerius in Allergic Rhinoconjunctivitis, sponsored by ALK-Abelló A/S.

Who is sponsoring NCT01740284?

NCT01740284 is sponsored by ALK-Abelló A/S.

What drugs are being tested in NCT01740284?

Interventions in NCT01740284: Grazax + Aerius, Grazax + placebo.

What condition does NCT01740284 study?

NCT01740284 studies Allergic Rhinoconjunctivitis.

Is NCT01740284 still recruiting?

NCT01740284 is currently completed. Last updated 7 February 2013.

Last reviewed 2013-02-07 · How we verify

NCT01740284: GT-19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Completed Phase 3 Last updated 7 February 2013

What this trial tests

Phase 3 trial testing Grazax + Aerius in Allergic Rhinoconjunctivitis in 46 participants. Completed in 1 January 2009.

Timeline

1 September 2008

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	ALK-Abelló A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	1 September 2008
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	1 location across Germany

Drugs / interventions tested

Grazax + Aerius — full drug profile →
Grazax + placebo — full drug profile →

Conditions studied

Allergic Rhinoconjunctivitis — all drugs for Allergic Rhinoconjunctivitis →

Sponsor

ALK-Abelló A/S — full company profile →

Who can join

Adults 18 to 65, any sex, with Allergic Rhinoconjunctivitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure
Time frame: 28 days following the first dosing

Sponsor's own description

Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Allergic Rhinoconjunctivitis

Currently open trials in the same condition.

NCT06778213 — Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomi · Phase 4 · recruiting

Other ALK-Abelló A/S trials

Trials by the same sponsor.

NCT06151938 — Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis · unknown
NCT05881577 — The Effect of Allergic Rhinitis on Educational Outcomes · unknown
NCT05655858 — Observational Study of Allergic Rhinitis in Children · completed
NCT04881461 — A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis · Phase 3 · completed
NCT04878354 — A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01740284 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ALK-Abelló A/S
Last refreshed: 7 February 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01740284.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing