Allergy Associates of Utah is currently conducting clinical trials for patients who suffer from asthma and allergies.

EXTRA

*A Study of Xolair in Subjects With Moderate to Severe Persistent Asthma*

* Purpose*

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy to high-dose ICS+LABA for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose ICS+LABA.

* Eligibility*

Ages Eligible for Study: 12 Years - 75 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

 

• Signed Informed Consent Form (in the case of a minor, consent must be given by the child's parent or legal guardian) and an informed assent, if applicable

• Be between the ages of 12 to 75 years

• Have had a history of moderate to severe asthma for at least one year prior to screening

• Have had treatment with a stable regimen of salmeterol 50 mcg BID or formoterol 12 mcg BID for at least 8 weeks prior to screening (with or without other asthma controller medications)

• Have had treatment with a stable regimen of high-dose ICS defined as a minimum of fluticasone DPI 500 mg BID or its comparable ex-valve dose for at least 8 weeks prior to screening

• Have a baseline FEV1 ≥ 40% and < 80% of predicted FEV1

• Have inadequately controlled asthma as defined below. In the 4 weeks prior to screening, the subject must exhibit inadequate asthma control as demonstrated by both of the following: History of persistent asthma symptoms on current therapy as defined by ≥ 1 nighttime awakening/week on average; Asthma symptoms during the day requiring rescue medication ≥ 2 days/week on average

• Have inadequately controlled asthma as defined below, for 2 consecutive weeks out of up to 4 weeks prior to randomization: History of persistent asthma symptoms on current therapy as defined by ≥ 1 nighttime awakening/week; Asthma symptoms during the day requiring rescue medication ≥ 2 days/week

• Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ICS defined as a minimum of fluticasone DPI 500 mg BID or its comparable ex-valve dose

• Have less than 10 pack-years smoking history

• Have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen (dog, cat, cockroaches [whole body], dermatophagoides farinae [dust mite], or dermatophagoides pteronyssinus) documented within the 12 months (diameter of wheal ≥ 3 mm vs. control) prior to screening

• If a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to entering the run-in period

• Subjects must meet the study drug-dosing table eligibility criteria (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg)

• Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study

• For the collection of additional blood samples for future research (optional): provide signed consent (in the case of a minor, consent must be given by the child's parent or legal guardian) and an informed assent, if applicable

Exclusion Criteria:

• Have had an asthma exacerbation requiring intubation within 12 months prior to screening

• Have active lung disease other than asthma

• Have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening

• Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.

• Have significant medical illness other than asthma

• Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening

• Have taken other investigational drugs within 30 days prior to screening

• Have been previously treated with Xolair

• Are unable or unwilling to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary)

• Have a history of drug or alcohol abuse

• Have elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)

• Are pregnant or lactating

EXACT

*A Study of Xolair in Subjects With Moderate to Severe Persistent Asthma*

* Purpose*

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy to high-dose ICS+LABA for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose ICS+LABA.

* Eligibility*

Ages Eligible for Study: 12 Years - 75 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

• Signed Informed Consent Form (in the case of a minor, consent must be given by the child's parent or legal guardian) and an informed assent, if applicable

• Be between the ages of 12 to 75 years

• Have had a history of moderate to severe asthma for at least one year prior to screening

• Have had treatment with a stable regimen of of salmeterol 50 mcg BID or formoterol 12 mcg BID for at least 8 weeks prior to screening (with or without other asthma controller medications)

• Have had treatment with a stable regimen of high-dose ICS defined as a minimum of fluticasone DPI 500 mg BID or its comparable ex-valve dose for at least 8 weeks prior to screening

• Have a baseline FEV1 ≥ 40% and < 80% of predicted FEV1

• Have inadequately controlled asthma as defined below. In the 4 weeks prior to screening, the subject must exhibit inadequate asthma control as demonstrated by both of the following: History of persistent asthma symptoms on current therapy as defined by ≥ 1 nighttime awakening/week on average; Asthma symptoms during the day requiring rescue medication ≥ 2 days/week on average

• Have inadequately controlled asthma as defined below, for 2 consecutive weeks out of up to 4 weeks prior to randomization: History of persistent asthma symptoms on current therapy as defined by ≥ 1 nighttime awakening/week; Asthma symptoms during the day requiring rescue medication ≥ 2 days/week

• Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ICS defined as a minimum of fluticasone DPI 500 mg BID or its comparable ex-valve dose

• Have less than 10 pack-years smoking history

• Have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen (dog, cat, cockroaches [whole body], dermatophagoides farinae [dust mite], or dermatophagoides pteronyssinus) documented within the 12 months (diameter of wheal ≥ 3 mm vs. control) prior to screening

• If a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to entering the run-in period

• Subjects must meet the study drug-dosing table eligibility criteria (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg)

• Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study

• For the collection of additional blood samples for future research (optional): provide signed consent (in the case of a minor, consent must be given by the child's parent or legal guardian) and an informed assent, if applicable

Exclusion Criteria:

• Have had an asthma exacerbation requiring intubation within 12 months prior to screening

• Have active lung disease other than asthma

• Have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening

• Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.

• Have significant medical illness other than asthma

• Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening

• Have taken other investigational drugs within 30 days prior to screening

• Have been previously treated with Xolair

• Are unable or unwilling to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary)

• Have a history of drug or alcohol abuse

• Have elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)

• Are pregnant or lactating

Grass Pollen Study

*Details Coming Soon*

* Purpose*

* Eligibility*

Ages Eligible for Study:

Inclusion Criteria:

Exclusion Criteria: