Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

Asthma Clinical Trial

Official title:

A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930461
• Other study ID #: VO72.12
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2013
• Last updated: December 17, 2015
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Paul-Ehrlich-InstitutCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Española de Medicamentos y Productos SanitariosDenmark: Danish Health and Medicines AuthorityBelgium: Federal Agency for Medicines and Health Products, FAMHPBulgaria: Bulgarian Drug AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAustria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Written informed consent.

• Male or female from 18 to 50 years of age.

• Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.

• Positive SPT to HDM and and HDM-specific IgE serum value = 0.7 kU/L.

• Stable asthma therapies.

• Spirometry (pre-bronchodilator) with best FEV1 = 70% of the predicted value.

• Spirometry with reversibility in FEV1 of = 12% and = 200 mL.

• Asthma Control Test™ (ACT) score = 19.

Exclusion Criteria:

• Former smoker with > 10 pack year history or current smoker.

• Patient with a urine level of cotinine = 500 ng/mL.

• Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.

• Patient who received allergen immunotherapy for HDM within the past 10 years.

• Ongoing immunotherapy for an aeroallergen other than house dust mite.

• Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.

• Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).

• Pregnant women or breast-feeding/lactating.

• Women with childbearing potential who are not using a medically accepted birth control method.

• Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in, or the outcome of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• House Dust Mite Allergy

Intervention

Biological:
• SLIT tablets of HDM allergen extracts, 3 different doses (A)
Two sublingual tablets daily for 13 months
• SLIT tablets of HDM allergen extracts, 3 different doses (B)
Two sublingual tablets daily for 13 months
• SLIT tablets of HDM allergen extracts, 3 different doses (C)
Two sublingual tablets daily for 13 months
• Placebo matching the SLIT tablets of HDM allergen extracts
Two sublingual tablets daily for 13 months

Locations

Country	Name	City	State
France	CHU Arnaud de Villeneuve	Montpellier
France	NHC, Hôpitaux Universitaires de Strasbourg	Strasbourg
Germany	Universitätsmedizin Berlin - Allergie-Centrum-Charité	Berlin
Poland	SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Lodzi	Lodz
Poland	Majorek-Olechowska Bernadetta	Tarnow

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Countries where clinical trial is conducted

France,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of Immunological parameters (HDM-specific IgE and IgG4 values)		13 months	No
Primary	Effect on the Asthma control test (ACT) score	Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma	13 months	No
Secondary	Number and percentage of subjects with treatment-emergent AEs		Measured during 13 months	Yes