RhinoconjunctivitisPhase 2NCT02150343
Phase II HDM-SPIRE Safety and Efficacy Study
A Phase 2 study testing HDM-SPIRE in people with Rhinoconjunctivitis, run by Circassia Limited at 98 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- HDM-SPIRE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 715 participants
- Where
- 98 sitesin 8 countries
- Study dates
- Sep 2014to 13 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
98 sites in 8 countries.
98 sites in 8 countries
United States56 sites
Study site
Asheville, North Carolina
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Bangor, Maine
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Bellevue, Nebraska
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Bellingham, Washington
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Bethesda, Maryland
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Bethlehem, Pennsylvania
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Birmingham, Alabama
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Blue Bell, Pennsylvania
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Brockton, Massachusetts
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Canton, Ohio
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Cincinnati, Ohio
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Dallas, Texas
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Evansville, Indiana
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Gaithersburg, Maryland
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Greenfield, Wisconsin
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Henrico, Virginia
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High Point, North Carolina
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Huntington Beach, California
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Iowa City, Iowa
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Kerrville, Texas
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Long Beach, California
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Madison, Wisconsin
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Medford, Oregon
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Mission Viejo, California
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Napa, California
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Normal, Illinois
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Ocean City, New Jersey
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Orange, California
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Owensboro, Kentucky
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Pittsburgh, Pennsylvania
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Plano, Texas
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Plymouth, Minnesota
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Portland, Oregon
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Providence, Rhode Island
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Redwood City, California
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Rochester, New York
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Rockville Centre, New York
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Rolling Hills Estates, California
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Roseville, California
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San Antonio, Texas
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San Diego, California
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Seattle, Washington
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Shiloh, Illinois
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South Burlington, Vermont
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St Louis, Missouri
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Stockbridge, Georgia
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Tallahassee, Florida
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Tampa, Florida
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Teaneck, New Jersey
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Tulsa, Oklahoma
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Vancouver, Washington
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Verona, New Jersey
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Walnut Creek, California
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Waterbury, Connecticut
Canada10 sites
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Hamilton, Ontario
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London, Ontario
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Montreal, Quebec
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Niagara, Ontario
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Ottawa, Ontario
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Québec, Quebec
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Saint Romuald, Quebec
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Toronto, Ontario
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Trois-Rivières, Quebec
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Windsor, Ontario
Spain8 sites
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Barcelona
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Bilbao, Vizcaya
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Donostia / San Sebastian, Guipuzcoa
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Girona, Catalonia
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Pamplona, Navarre
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Sabadell, Barcelona
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Santander, Cantabria
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Seville
Italy7 sites
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Ancona, Torrette Di Ancona
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Genova
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Milan
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Parma
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Pavia
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Roma
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Siena
Germany6 sites
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Berlin
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Dresden, Saxony
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Essen, North Rhine-Westphalia
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Goch, North Rhine-Westphalia
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Hamburg
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Heidelberg, Baden-Wurttemberg
France4 sites
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Bas Rhin, Strasbourg
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Gironde, Pessac
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Meurthe-et-Moselle, Vandoeuvre Les Nancy
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Reims, Marne
South Africa4 sites
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Cape Town, Western Cape
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Durban, KwaZulu-Natal
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eMkhomazi, KwaZulu-Natal
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Ottawa, KwaZulu-Natal
Netherlands3 sites
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Almere Stad
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Amsterdam
Study site
Beek
About this 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
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
- Conditions
- Rhinoconjunctivitis
- Being tested
- HDM-SPIRE, Placebo
- Keywords
- Cat allergy, Rhinoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM-SPIREDrug
1 dose every 4 weeks
PlaceboDrug
1 dose every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| HMD-SPIRE Treatment 1 | Experimental | 4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart Receives: Drug: HDM-SPIRE; Drug: Placebo |
| HDM-SPIRE Treatment 2 | Experimental | 4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart Receives: Drug: HDM-SPIRE |
| HDM-SPIRE Treatment 3 | Experimental | 4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart Receives: Drug: HDM-SPIRE; Drug: Placebo |
| Placebo | Placebo comparator | 8 x placebo 4 weeks apart Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 50 to 52 after randomisation
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 50 to 52 after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startSep 2014
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150343
- Sponsor's protocol ID
- TH005
- Status last verified
- May 2018
- First submitted
- 27 May 2014
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02150343
- Acronym / sponsor ID
- TH005
- Conditions
- Rhinoconjunctivitis
- Keywords
- Cat allergy, Rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Sep 2014
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HMD-SPIRE Treatment 1 | Experimental | Drug: HDM-SPIRE, Drug: Placebo4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart |
| HDM-SPIRE Treatment 2 | Experimental | Drug: HDM-SPIRE4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart |
| HDM-SPIRE Treatment 3 | Experimental | Drug: HDM-SPIRE, Drug: Placebo4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart |
| Placebo | Placebo comparator | Drug: Placebo8 x placebo 4 weeks apart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM-SPIRE1 dose every 4 weeks | Drug | HDM-SPIRE Treatment 2, HDM-SPIRE Treatment 3, HMD-SPIRE Treatment 1 |
| Placebo1 dose every 4 weeks | Drug | HDM-SPIRE Treatment 3, HMD-SPIRE Treatment 1, Placebo |
Primary outcome
Combined Score of Symptoms and Allergy Medication
Time frame: Weeks 50 to 52 after randomisation
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.
7 secondary outcomes
Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo
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
Time frame: Weeks 50 to 52 after randomisation
Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo
Time frame: Weeks 50 to 52 after randomisation
Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
Time frame: Weeks 50 to 52 after randomisation
Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo
Time frame: Weeks 50 to 52 after randomisation
Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo
Time frame: Weeks 50 to 52 after randomisation
Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo
Time frame: Weeks 50 to 52 after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
98 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDM-SPIRE in people with Rhinoconjunctivitis, run by Circassia Limited at 98 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Canada, Spain, Italy, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Score of Symptoms and Allergy Medication (time frame: Weeks 50 to 52 after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.