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

• ClinicalTrials.gov Identifier: NCT01316315
• Recruitment Status: Completed
• First Posted: March 16, 2011
• Results First Posted: March 11, 2014
• Last Update Posted: May 5, 2014
• Sponsor: Nivalis Therapeutics, Inc.
• Information provided by (Responsible Party): Nivalis Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Active; Drug: Placebo	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo-Controlled, Two-Period, Cross-Over Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
• Study Start Date: March 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active; N6022 - 5 mg	Drug: Active; A 5 mg single dose given intravenously via syringe pump over 1 minute.; Other Name: N6022
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Same as active

Outcome Measures

Primary Outcome Measures :

1. Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing [ Time Frame: 24 hours ]
   These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.

Secondary Outcome Measures :

1. Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing [ Time Frame: 8 hours ]
   These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.
2. To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. [ Time Frame: 10 Weeks ]
   Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.

Other Outcome Measures:

1. Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing [ Time Frame: 7 Days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Colorado

National Jewish Health

Denver, Colorado, United States, 80206

United States, North Carolina

Duke Asthma, Allergy and Airway Center

Durham, North Carolina, United States, 27704

Sponsors and Collaborators

Nivalis Therapeutics, Inc.

Investigators

• Principal Investigator: Rhohit K Katial, MD; National Jewish Health
• Principal Investigator: Monica Kraft, MD; Duke Asthma, Allergy and Airway Center

More Information

Additional Information:

Sponsor 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nivalis Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01316315
• Other Study ID Numbers: N6022-2A1-02
• First Posted: March 16, 2011
• Results First Posted: March 11, 2014
• Last Update Posted: May 5, 2014
• Last Verified: April 2014

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases