Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01316315
- Run by
- Nivalis Therapeutics, Inc.
- People needed
- 14
- Starts
- 2011-03-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2014-05-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- National Jewish Health — Denver, Colorado, United States
- Duke Asthma, Allergy and Airway Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.