Clinical trial NCT02150343: Phase II HDM-SPIRE Safety and Efficacy Study
Official title: A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Keywords: Cat allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2014-05-29
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years.
* Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
* Mean TRSS ≥10
* Positive skin prick test to Der p and Der f.
* Dep p and Der f specific IgE ≥0.7 kU/L

Exclusion Criteria:

* Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
* FEV1 \<80% of predicted.
* Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
* Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
* Clinically relevant abnormalities detected on physical examination.
* History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Primary outcomes:
measure: Combined Score of Symptoms and Allergy Medication
timeFrame: Weeks 50 to 52 after randomisation
Secondary outcomes:
measure: Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
measure: Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline
timeFrame: Weeks 50 to 52 after randomisation
measure: Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
measure: Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
measure: Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
measure: Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
measure: Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo
timeFrame: Weeks 50 to 52 after randomisation
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Napa
country: United States
state: California
city: Orange
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Rolling Hills Estates
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Normal
country: United States
state: Illinois
city: Shiloh
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Owensboro
country: United States
state: Kentucky
city: Bangor
country: United States
state: Maine
city: Bethesda
country: United States
state: Maryland
city: Gaithersburg
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Plymouth
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: Ocean City
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Verona
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Rockville Centre
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Blue Bell
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Dallas
country: United States
state: Texas
city: Kerrville
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: South Burlington
country: United States
state: Vermont
city: Henrico
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Greenfield
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Niagara
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: St Romuald
country: Canada
state: Quebec
city: Trois Rivieres
country: Canada
state: Quebec
city: Reims
country: France
state: Marne
city: Gironde
country: France
state: Pessac
city: Bas Rhin
country: France
state: Strasbourg
city: Meurthe-et-Moselle
country: France
state: Vandoeuvre Les Nancy
city: Heidelberg
country: Germany
state: Baden Wuerttemberg
city: Essen
country: Germany
state: Nordrhein Westfalen
city: Goch
country: Germany
state: Nordrhein Westfalen
city: Dresden
country: Germany
state: Saxony
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Ancona
country: Italy
state: Torrette Di Ancona
city: Genova
country: Italy
city: Milano
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Almere
country: Netherlands
city: Amsterdam
country: Netherlands
city: Beek
country: Netherlands
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Ottawa
country: South Africa
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
state: KwaZulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Sabadell
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Girona
country: Spain
state: Catalonia
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Pamplona
country: Spain
state: Navarre
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Sevilla
country: Spain
Study officials:
References: