Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

NCT ID: NCT01316315

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.

Detailed Description

The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

N6022 - 5 mg

Group Type: EXPERIMENTAL

Active

Intervention Type: DRUG

A 5 mg single dose given intravenously via syringe pump over 1 minute.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Same as active

Interventions

Active

A 5 mg single dose given intravenously via syringe pump over 1 minute.

Intervention Type: DRUG

Placebo

Same as active

Intervention Type: DRUG

Other Intervention Names

N6022

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at screening.
• Patient has a ≤ 5 pack years smoking history and nonsmoking for ≥ one year.
• Documented history of mild bronchial asthma, first diagnosed at least 6 months and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
• Pre-bronchodilator FEV1 ≥ 75% of predicted at screening.
• Sensitivity to methacholine with a provocation concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of ≤ 8 mg/ml at screening.
• Demonstrated stable lung function during screening with ≤10% variability between two assessments of FEV1 taken at least 7 days apart at approximately the same time of day.

Exclusion Criteria

• Hypertension at screening is defined as systolic blood pressure (BP) >150 mmHg or diastolic BP > 90mmHg.
• Respiratory tract infection and/or exacerbation of asthma within prior 4 weeks
• History of life-threatening asthma
• Administration of steroids within 4 weeks of the screening visit.
• History of being unable to tolerate or complete MCh testing.
• Blood donation (500 mL) within 3 months of starting the clinical study.
• Tested positive for hepatitis C antibody or hepatitis B surface antigen.
• Tested positive for human immunodeficiency virus (HIV) antibodies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nivalis Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhohit K Katial, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Monica Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Asthma, Allergy and Airway Center

Locations

National Jewish Health

Denver, Colorado, United States

Duke Asthma, Allergy and Airway Center

Durham, North Carolina, United States

Countries

United States

References

Que LG, Yang Z, Lugogo NL, Katial RK, Shoemaker SA, Troha JM, Rodman DM, Tighe RM, Kraft M. Effect of the S-nitrosoglutathione reductase inhibitor N6022 on bronchial hyperreactivity in asthma. Immun Inflamm Dis. 2018 Jun;6(2):322-331. doi: 10.1002/iid3.220. Epub 2018 Apr 11.

Reference Type: DERIVED

PMID: 29642282 (View on PubMed)

Related Links

http://n30pharma.com/

Sponsor

Other Identifiers

N6022-2A1-02

Identifier Type: -

Identifier Source: org_study_id