Trial Outcomes & Findings for Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma (NCT NCT01316315)

Last Updated: 2014-05-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

24 hours

Results posted on

2014-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Active N6022 - Active 5 mg	Placebo Non-Active
Sequence 1 STARTED	7	7
Sequence 1 COMPLETED	7	7
Sequence 1 NOT COMPLETED	0	0
Sequence 2 STARTED	7	7
Sequence 2 COMPLETED	7	7
Sequence 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=7 Participants N6022 - 5 mg	Placebo n=7 Participants Non-Active	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Any patient that received a dose of N6022 or placebo.

Outcome measures

Outcome measures
Measure	N6022 n=14 Participants Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.	Placebo n=13 Participants Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	1.48 mg/mL Standard Error .093	-0.2 mg/mL Standard Error 0.3

SECONDARY outcome

Timeframe: 8 hours

Population: Any patient that received a dose of N6022 or Placebo

Outcome measures

Outcome measures
Measure	N6022 n=14 Participants Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.	Placebo n=13 Participants Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	0.3 mg/mL Standard Error 0.63	-0.54 mg/mL Standard Error 0.33

SECONDARY outcome

Timeframe: 10 Weeks

Population: Any patient that received a dose of N6022 or placebo

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.

Outcome measures

Outcome measures
Measure	N6022 n=7 Participants Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.	Placebo n=6 Participants Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	11 Adverse Events	9 Adverse Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 Days

Population: Any patient that received a dose of N6022 or Placebo

Outcome measures

Outcome measures
Measure	N6022 n=14 Participants Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.	Placebo n=13 Participants Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing	0.74 mg/mL Standard Error 1.01	-0.38 mg/mL Standard Error .68

Adverse Events

Active

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Janice M. Troha

N30 Pharmaceuticals Inc.

Phone: 720-945-7714

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees with the use of results of the clinical study for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals. If necessary, the competent authorities will be notified of the investigator's name, address, qualifications, and extent of involvement. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with the Sponsor in advance.
Publication restrictions are in place

Restriction type: OTHER

Measure	Active n=14 participants at risk N6022 - Active 5 mg	Placebo n=13 participants at risk Non-Active
Gastrointestinal disorders Abdominal Pain Upper	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
General disorders Injection Site Hematoma	14.3% 2/14 • Number of events 2 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Injury, poisoning and procedural complications Blood Creatinine Increased	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations Blood LDH	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations Blood Phosphorous Decreased	14.3% 2/14 • Number of events 2 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	15.4% 2/13 • Number of events 2 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations Blood Urine Present	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Nervous system disorders Headache	35.7% 5/14 • Number of events 5 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	23.1% 3/13 • Number of events 3 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Nasal Turminate Abnormality	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Pharyngeal Erthyma	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Respiratory Fatigue	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Respiratory, thoracic and mediastinal disorders Allergic Rhinnitis	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Skin and subcutaneous tissue disorders Eczema	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Skin and subcutaneous tissue disorders Erthyma	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Vascular disorders Flushing	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	0.00% 0/13 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Vascular disorders Thrombophlebitis	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Gastrointestinal disorders Nausea	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
General disorders Injection Site Erthyma	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
General disorders Injection Site Induration	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
General disorders Injection Site Pain	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
General disorders Tenderness	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	23.1% 3/13 • Number of events 3 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations ALT Increased	7.1% 1/14 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations AST Increased	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Investigations Blood Bilirubin Increased	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.
Vascular disorders Thrombosis	0.00% 0/14 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.	7.7% 1/13 • Number of events 1 • 8 Months Patients were followed from signing consent through both sequences of the crossover design.