Efficacy and Safety Study in Mild Asthmatic Subjects Undergoing Allergen Challenge
- Conditions
- Mild asthma with allergen challengeMedDRA version: 20.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-001729-28-GB
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. Male or female adults between 18 and 60 years of age
2. Body Mass Index (BMI) between 18 and 32 kg/m² at Screening
3. Written informed consent obtained from the subject prior to any study Screening procedures
4. Previously documented diagnosis of asthma for at least 6 months prior to Screening or a history of at least 6 months of episodic symptoms of airflow obstruction such as wheezing and/or chest tightness with other significant lung diseases ruled out (e.g., chronic obstructive pulmonary disease [COPD])
5. Forced expiratory volume in one second (FEV1) =70% of predicted value at Screening (based on American Thoracic Society [ATS]/ European Respiratory Society [ERS] standards
6. A positive skin prick test to test allergen [defined as the indurations of skin test wheal =2 mm larger in diameter than diameter of control wheal
7. Early-phase asthmatic response (EAR) of at least 20% and a late-phase asthmatic response (LAR) of as at least 15% to inhaled allergen challenge [response defined as a decrease from pre-challenge in FEV1 on 2 consecutive occasions within 0 to <3 hours of last allergen challenge administered for EAR and within 3 to 10 hours for LAR]
8. a. Sexually active women, unless surgically sterile (confirmed by documentation) or at least 2 year post-menopausal (confirmed by FSH blood level at Screening), must have a negative serum pregnancy test result at Screening and agree to use two effective methods of contraception from the signing of informed consent through 21 days after the last dose of study drug
b. Sexually active men, unless surgically sterile, must agree to use an effective method of birth control from the signing of informed consent through 21 days after the last dose of study drug
9. Subject has the willingness and ability to complete all the study requirements, instructions, or study related restrictions through the final Safety Follow-up Phone Screen 21 days after last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor in a previous clinical study
2. History of allergy or reaction to any component of the study drug formulation, such as excipients in the study drug capsule or oral solution (See Section 7.1)
3. Acute asthma exacerbations leading to hospitalization, emergency room visit, or unscheduled health care provider visit, within 6 weeks prior to Screening or any previous history of intubation or admission to an intensive care unit for asthma
4. Use of any medication for the treatment of asthma other than a short-acting ß2 agonist (as needed) within the 4 weeks prior to Screening and no significant changes in short-acting ß2 agonist use over the 6 weeks prior to Screening
5. Use if anti-IgE therapy (omalizumab) within 12 weeks prior to Screening
6. Upper or lower respiratory tract infections or acute illnesses or evidence of on-going clinically significant infection within the 4 weeks prior to Screening
7. If undergoing concomitant allergy vaccination therapy (desensitization immunotherapy), <3 months of stable maintenance doses prior to the Baseline allergen challenge; any allergy concomitant vaccination therapy leading to desensitization to any of the allergens used in the allergen challenge
8. Participation in another clinical study within 90 days prior to study Screening or until completion of the final Safety Follow-up Visit
9. Blood donation (=500 mL) within 3 months before Screening
10. Any history of treatment with a leukocyte-depleting agent (eg, rituximab, alemtuzumab)
11. Positive laboratory test result for hepatitis B or C or HIV-1 or HIV-2 at Screening
12. A positive screen result for active or latent tuberculosis (verified by either PPD skin test or Quantiferon blood test at Screening)
13. History of significant systemic disease (e.g., cancer, coronary artery disease, seizure disorder) as judged by the Investigator
14. Currently pregnant or lactating
15. Smoking within 6 months prior to Screening or a smoking history of =10 pack-years
16. A positive screen for drug and/or alcohol abuse at Screening or reported use of illegal drugs or history of abuse of prescription drugs or alcohol within 1 year before Screening
17. Planned elective surgery from the time of Screening through the final Safety Follow-up Visit
18. Clinically significant abnormalities on safety laboratory tests, 12-lead ECG, vital signs, or physical examination at Screening, based on the medical judgment of the Investigator
19. Vulnerable subjects (i.e., those subjects imprisoned or lawfully kept in an institution)
20. Subject is an employee or direct relative of an employee of the contract research organization (CRO) or Infinity Pharmaceuticals Inc.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method