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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316315
• Other study ID #: N6022-2A1-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 7, 2011
• Last updated: April 17, 2014
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Nivalis Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Active
A 5 mg single dose given intravenously via syringe pump over 1 minute.
• Placebo
Same as active

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado
United States	Duke Asthma, Allergy and Airway Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nivalis Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing		7 Days	No
Primary	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	No
Secondary	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.	8 hours	No
Secondary	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.	10 Weeks	Yes

External Links

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