Phase 2
N=14
Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01316315 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing — 1.48; -0.2 mg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nivalis Therapeutics, Inc.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing |
1.48; -0.2 | — |
| SECONDARY Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing |
0.3; -0.54 | — |
| SECONDARY To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. |
11; 9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01316315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.