AsthmaPhase 1/2NCT01316315
Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
A Phase 1/2 study testing Active in people with Asthma, run by Nivalis Therapeutics, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Active
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health
Denver, Colorado, 80206
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, 27704
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Active, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDrug
Also called N6022
A 5 mg single dose given intravenously via syringe pump over 1 minute.
PlaceboDrug
Same as active
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | N6022 - 5 mg Receives: Drug: Active |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 8 hours
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.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rhohit K Katial, MD, Principal investigator, National Jewish HealthMonica Kraft, MD, Principal investigator, Duke Asthma, Allergy and Airway Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316315
- Sponsor's protocol ID
- N6022-2A1-02
- Status last verified
- Apr 2014
- First submitted
- 7 Mar 2011
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Que LG, Yang Z, Lugogo NL, Katial RK, Shoemaker SA, Troha JM, Rodman DM, Tighe RM, Kraft M. Effect of the S-nitrosoglutathione reductase inhibitor N6022 on bronchial hyperreactivity in asthma. Immun Inflamm Dis. 2018 Jun;6(2):322-331. doi: 10.1002/iid3.220. Epub 2018 Apr 11.
PubMed 29642282
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01316315
- Acronym / sponsor ID
- N6022-2A1-02
- Conditions
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nivalis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: ActiveN6022 - 5 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveAlso: N6022A 5 mg single dose given intravenously via syringe pump over 1 minute. | Drug | Active |
| PlaceboSame as active | Drug | Placebo |
Primary outcome
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
Time frame: 24 hours
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.
2 secondary outcomes
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing
Time frame: 8 hours
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.
Time frame: 10 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29642282Que LG, Yang Z, Lugogo NL, Katial RK, Shoemaker SA, Troha JM, Rodman DM, Tighe RM, Kraft M. Effect of the S-nitrosoglutathione reductase inhibitor N6022 on bronchial hyperreactivity in asthma. Immun Inflamm Dis. 2018 Jun;6(2):322-331. doi: 10.1002/iid3.220. Epub 2018 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhohit K Katial, MD principal investigator
National Jewish Health
Monica Kraft, MD principal investigator
Duke Asthma, Allergy and Airway Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active in people with Asthma, run by Nivalis Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.