Efficacy of SLITone in House Dust Mite Allergic Patients

NCT00633919 | Completed Phase 2 Results

• 2 other identifiers: E02/04/SLIT1-MEudraCT - 2005-004731-21
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).

Conditions

Allergy

Keywords

House dust mites; Sublingual immunotherapy; Allergy; Allergic asthma

Outcome Measures

Primary Outcomes (1)

• Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008

  Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).

  8 weeks

Secondary Outcomes (4)

• Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007

  8 weeks

• Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008

  8 weeks

• Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008

  8 weeks

• Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007

  8 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

SLITone Dermatophagoides Mix

Biological: SLITone(TM) Dermatophagoides mix; Drug: Salbutamol inhaler; Drug: Budesonide/formoterol inhaler; Drug: Prednisone tablet; Drug: Desloratadine tablet; Drug: Budesonide nasal spray

Placebo

PLACEBO COMPARATOR

SLITone Placebo

Biological: Placebo; Drug: Salbutamol inhaler; Drug: Budesonide/formoterol inhaler; Drug: Prednisone tablet; Drug: Desloratadine tablet; Drug: Budesonide nasal spray

Interventions

SLITone(TM) Dermatophagoides mix BIOLOGICAL

Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years

Active

Placebo BIOLOGICAL

Sublingual immunotherapy once daily for 2 years

Placebo

Salbutamol inhaler DRUG

200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use)

Also known as: Ventilastin

Active; Placebo

Budesonide/formoterol inhaler DRUG

80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use)

Also known as: Symbicort

Active; Placebo

Prednisone tablet DRUG

5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use)

Active; Placebo

Desloratadine tablet DRUG

5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use)

Also known as: Aerus

Active; Placebo

Budesonide nasal spray DRUG

64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use)

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.
• Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent).
• Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.
• If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test.
• Willingness to comply with this protocol.

You may not qualify if:

• FEV1 \< 70% of predicted value with appropriate medication.
• Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent.
• A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites.
• Chronic sinusitis.
• Aspirin or sulfite intolerance.
• Chronic obstructive pulmonary disease.
• Current severe atopic dermatitis.
• Severe asthma.
• Use of an investigational drug within 30 days prior to screening.
• Previous immunotherapy with house dust mite allergens for at least 2 years within the previous 10 years.
• Physical examination with clinically relevant findings.
• Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic disease).
• Immunosuppressive treatment.
• A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
• Unlikely to be able to complete the trial.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Fernando Rodríguez

Santander, Cantabria, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Prednisone; desloratadine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations; Pregnadienediols; Pregnadienes

Limitations and Caveats

Retrospectively, trial design (medication use did not reflect the asthma status of subjects), and subject number (low power) and characteristics (mild, well-controlled asthma; low medication use needed) were not optimal for this trial purpose.

Results Point of Contact

• Title: Santiago Martín - Trial Manager
• Organization: ALK-Abelló S.A.

santiago.martin@alk-abello.com

+34 913276127

Study Officials

• Santiago Martín, PhD

  Clinical Research Director, ALK-Abelló, S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: June 8, 2011
• Results First Posted: February 21, 2011

Record last verified: 2011-06

Locations

ES (1)