NCT02126111: GRAMAL

Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis

Completed Phase 2 Last updated 5 November 2016

What this trial tests

Phase 2 trial testing DEPIGOID phleum in Allergic Rhinitis in 56 participants. Completed in 1 April 2016.

Timeline

1 October 2010

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Plaza del Hospital Civil
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	56
Start date	1 October 2010
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	2 locations across Spain

Drugs / interventions tested

• DEPIGOID phleum — full drug profile →
• DEPIGOID Placebo

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Plaza del Hospital Civil

Who can join

Adults 18 to 55, any sex, with Allergic Rhinitis. 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.

• Symptoms and medication scores comparison between active and placebo group
  Time frame: two years
  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 p

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oral Abstract Session OAS
   · 2017
2. Abstracts from the 11th Symposium on Experimental Rhinology and Immunology of the Nose (SERIN 2017)
   Gracia I, Rondón C, Campo P, Prieto A, et al · · 2017