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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
N30 Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01316315
First received: March 7, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Active
Drug: Placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by N30 Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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.

  • To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma. [ Time Frame: 10 Weeks ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
N6022 - 5 mg
Drug: Active
A 5 mg single dose given intravenously via syringe pump over 1 minute.
Other Name: N6022
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Same as active
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316315

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, North Carolina
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
N30 Pharmaceuticals, Inc.
Investigators
Principal Investigator: Rhohit K Katial, MD National Jewish Health
Principal Investigator: Monica Kraft, MD Duke Asthma, Allergy and Airway Center
  More Information

Additional Information:
No publications provided

Responsible Party: N30 Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01316315     History of Changes
Other Study ID Numbers: N6022-2A1-02
Study First Received: March 7, 2011
Results First Received: January 28, 2014
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014