Phase II HDM-SPIRE Safety and Efficacy Study

Circassia Limited715 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

715

Conditions

Rhinoconjunctivitis

Interventions

HDM-SPIREDRUG

1 dose every 4 weeks

PlaceboDRUG

1 dose every 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (98)

Outcomes

Primary Outcomes

Combined Score of Symptoms and Allergy Medication

The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3. The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.

Time frame: Weeks 50 to 52 after randomisation

Secondary Outcomes

Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo

The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (50-52 weeks after randomisation). RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). Questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.

Time frame: Weeks 50 to 52 after randomisation

Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline

A Global Impression of Change in Rhinoconjunctivitis Symptoms assessment was completed by subjects at the final follow-up visit. Subjects rated their overall allergy symptoms at the end of the study relative to baseline on a seven-point scale as follows:0. very much better; 1. moderately better; 2. a little better; 3. unchanged; 4. a little worse; 5. moderately worse; 6. very much worse. For reporting the individual categories were grouped as follows: moderately or very much better; any improvement; no change and any worsening. Subjects could therefore be reported in more than group and the total number reported does not match the overall number of participants analysed.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Huntington Beach, California, United States

Unnamed facility

Long Beach, California, United States

Unnamed facility

Mission Viejo, California, United States

Unnamed facility

Napa, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

Redwood City, California, United States

Unnamed facility

Rolling Hills Estates, California, United States

Unnamed facility

Roseville, California, United States

Unnamed facility

San Diego, California, United States

...and 88 more locations

Time frame: Weeks 50 to 52 after randomisation

Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo

Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in HDM-SPIRE treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.

Time frame: Weeks 50 to 52 after randomisation

Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo

Mean daily Total Non-nasal Symptom Score (TNNSS) in HDM-SPIRE treatment groups compared to placebo. TNNSS was the sum of all the non-nasal symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TNNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.

Time frame: Weeks 50 to 52 after randomisation

Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo

TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation.

Time frame: Weeks 50 to 52 after randomisation

Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo

Mean RMS (Rescue medication score) in HDM-SPIRE treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 50-52 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.

Time frame: Weeks 50 to 52 after randomisation

Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo

The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 50-52 weeks after randomisation.

Time frame: Weeks 50 to 52 after randomisation