Clinical trial NCT01511302: Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma
Official title: A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Revalesio Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 65
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 determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.


Eligibility criteria: Inclusion Criteria:

* Male or female non-smokers, aged between 18 and 65 years.
* Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.
* Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.
* Normal 12-lead ECG at Screening.
* Normal single view chest x-ray at Screening.
* Men and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57).
* Women of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day 22.
* Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary, informed consent.

Exclusion Criteria:

* Chronic or acute disease that might interfere with the evaluation of RNS60.
* Pregnancy, intent to become pregnant, or breastfeeding.
* Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).
* Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.
* Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22.
* Infections that require intravenous antibiotic therapy.
* Significant organ dysfunction, including cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry.
* Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
* Treatment with any investigational drugs, therapies, or medical devices within 4 weeks prior to study entry.
* Any use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period.
* Use of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.

Primary outcomes:
measure: Change in Forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline to 56 days
Secondary outcomes:
measure: Change in peak expiratory flow
timeFrame: Baseline to 56 days
measure: Change in quality of life
timeFrame: 56 days
measure: Change in rescue inhaler usage
timeFrame: 56 days
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Riverside
country: United States
facility: Integrated Research Group
state: California
Study officials:
References: