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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active
Placebo
Sponsored by
Nivalis Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Jewish Health
  • Duke Asthma, Allergy and Airway Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

N6022 - 5 mg

Placebo

Outcomes

Primary Outcome Measures

Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
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

Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing
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.
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.
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.

Full Information

First Posted
March 7, 2011
Last Updated
April 17, 2014
Sponsor
Nivalis Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01316315
Brief Title
Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nivalis Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
N6022 - 5 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Active
Other Intervention Name(s)
N6022
Intervention Description
A 5 mg single dose given intravenously via syringe pump over 1 minute.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Same as active
Primary Outcome Measure Information:
Title
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing
Description
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.
Time Frame
8 hours
Title
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.
Description
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.
Time Frame
10 Weeks
Other Pre-specified Outcome Measures:
Title
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhohit K Katial, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica Kraft, MD
Organizational Affiliation
Duke Asthma, Allergy and Airway Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Duke Asthma, Allergy and Airway Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29642282
Citation
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.
Results Reference
derived
Links:
URL
http://n30pharma.com/
Description
Sponsor

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

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