Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
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
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 asthma
Started Mar 2011
Typical duration for phase_1 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 11, 2014
CompletedMay 5, 2014
April 1, 2014
8 months
March 7, 2011
January 28, 2014
April 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 hours
Secondary Outcomes (2)
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing
8 hours
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.
10 Weeks
Other Outcomes (1)
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing
7 Days
Study Arms (2)
Active
EXPERIMENTALN6022 - 5 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Jewish Health
Denver, Colorado, 80206, United States
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, 27704, United States
Related Publications (1)
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.
PMID: 29642282DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janice M. Troha
- Organization
- N30 Pharmaceuticals Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Rhohit K Katial, MD
National Jewish Health
- PRINCIPAL INVESTIGATOR
Monica Kraft, MD
Duke Asthma, Allergy and Airway Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 16, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
May 5, 2014
Results First Posted
March 11, 2014
Record last verified: 2014-04