Clinical trial NCT01316315: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asthma
Lead sponsor: Nivalis Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
timeFrame: 24 hours
Secondary outcomes:
measure: Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing
timeFrame: 8 hours
measure: To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.
timeFrame: 10 Weeks
Other outcomes:
measure: Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing
timeFrame: 7 Days
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Durham
country: United States
facility: Duke Asthma, Allergy and Airway Center
state: North Carolina
Study officials:
affiliation: National Jewish Health
name: Rhohit K Katial, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Asthma, Allergy and Airway Center
name: Monica Kraft, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.