AsthmaPhase 2NCT00688467
Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
A Phase 2 study testing Navarixin in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
Evaluation of treatment in participants with mild asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Navarixin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2008to 1 Mar 2009
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman 18 to 65 years of age of any race.
- Has mild, stable, allergic asthma as defined by American Thoracic Society criteria.
- Has history of episodic wheezing and shortness of breath.
- Has Forced Expiratory Volume in 1 second (FEV1) of at least 70% of predicted at Screening and within 10% of preallergen screening value at both baselines.
- Has positive methacholine challenge at Screening. Methacholine challenges are considered positive if decreases of at least 20% in the FEV1 occur at a concentration of less than or equal to 16 mg/mL.
- Baseline methacholine PC20 (concentration that initiated a 20% fall in FEV1) must be within 1 doubling concentration of the preallergen screening PC20 to enter treatment.
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- Has positive skin-prick test to common allergens (cat, dust mite, grass, pollen).
- Has a positive Early Asthmatic Response of >=20% fall in FEV1 measured from the FEV1 immediately prior to challenge, and Late Asthmatic Response of >=15% fall in FEV1 from the FEV1 measured immediately prior to challenge during Screening period.
- Has been free from asthma exacerbation for at least 4 weeks before Screening. An exacerbation is defined as an occurrence of any clinical deterioration of asthma that requires emergency treatment, hospitalization due to asthma, or treatment with additional medication, as judged by the clinical investigator.
- Has been free from relevant seasonal allergen exposure for at least 4 weeks before the study and be able to remain so for the duration of the study.
- Has a current nonsmoking status. If previous smokers, cumulative smoking history must be fewer than 10 pack-years (pack-year=20 cigarettes smoked daily for 1 year). Previous smokers must not have smoked within 1 year before Screening.
- Is willing to give written informed consent to participate in the study.
- Has the ability to comply with the dosing regimen, to adhere to the visit schedule, and to participate in all treatment procedures, including sputum induction.
- Female participant of childbearing potential must have a negative serum pregnancy tests (human chorionic gonadotropin; hCG) at Screening and must use a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agrees to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control include hormonal implants, oral contraceptives, hormonal patches, intravaginal ring, medically acceptable prescribed intrauterine devices (IUDs), and a monogamous relationship with a male partner who has had a vasectomy. A female participant who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female participant should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
- Participants, if male and sexually active with women of childbearing potential, must agree to use an adequate form of contraception for the duration of the study and to have sexual relations with only those women who use a highly effective birth control method.
- Clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
Who cannot join
- Has had a diagnosis of chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis) other than mild allergic asthma, or has a history of having been intubated.
- Has had a worsening of a respiratory tract infection within 4 weeks before Screening.
- Has had any clinically significant abnormality; history of clinically significant hypotensive episodes of fainting, dizziness, or lightheadedness; history or symptoms of cardiovascular disease; significant neurologic disease; or hematologic abnormality, including coagulopathy; or has a medication regimen or clinically relevant medical condition other than asthma that may interfere with the effect of study medication.
- Had a peripheral blood neutrophil (PBN) count of <3 × 10^9/L at the Screening Visit.
- Has an allergy/sensitivity to the study drug or its excipients.
- Is pregnant, breast-feeding, or intends to become pregnant during the study.
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- Has used any investigational drug within 30 days or 5 half-lives of Screening.
- Is presently participating in any other clinical study.
- Is part of the staff personnel directly involved with this study
- Is a family member of the investigational study staff.
- Has received any treatment prohibited by the protocol (Table 3), or any medication that may interfere with the effect of the study medication more recently than the indicated washout period prior to Screening, or must continue to receive the prohibited treatment.
About this study
Official title: A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of SCH 527123 in Subjects With Allergen-Induced Asthma
Evaluation of treatment in participants with mild asthma.
Read the detailed description
To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced late asthmatic response (LAR) in participants with mild asthma.
- Conditions
- Asthma
- Being tested
- Navarixin, Placebo
- Keywords
- Neutrophilic Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavarixinDrug
Also called SCH 527123
30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2
PlaceboDrug
Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2
| Study group | Role | What they receive |
|---|---|---|
| Navarixin → Placebo | Experimental | Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2 Receives: Drug: Navarixin; Drug: Placebo |
| Placebo → Navarixin | Experimental | Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2 Receives: Drug: Navarixin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
Measured: Baseline and between 3 and 7 hours after allergen challenge
Secondary outcomes (12)
Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin
Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
Measured: Baseline and between 3 and 7 hours after allergen challenge
Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge
This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.
Measured: Baseline and 24 hours after allergen challenge
Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
Measured: Baseline and between 0 to 2 hours after allergen challenge
Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin
Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
Measured: Baseline and between 0 to 2 hours after allergen challenge
Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.
Measured: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.
Measured: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.
Measured: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.
Measured: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.
Measured: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.
Measured: Baseline and 7 and 24 hours after allergen challenge
Number of Participants With an Adverse Event (AE)
An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.
Measured: Up to 48 days
Number of Participants Discontinued From the Study Because of an Adverse Event
An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.
Measured: Up to 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study start1 Jun 2008
- Primary completion1 Mar 2009
- Study completion1 Mar 2009
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.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688467
- Sponsor's protocol ID
- P05363
- Other IDs
- MK-7123-016
- Status last verified
- Dec 2018
- First submitted
- 29 May 2008
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of SCH 527123 in Subjects With Allergen-Induced Asthma
- ClinicalTrials.gov ID
- NCT00688467
- Acronym / sponsor ID
- P05363
- Conditions
- Asthma
- Keywords
- Neutrophilic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 1 Mar 2009 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of treatment in participants with mild asthma.
Detailed description
To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced late asthmatic response (LAR) in participants with mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navarixin → Placebo | Experimental | Drug: Navarixin, Drug: PlaceboNavarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2 |
| Placebo → Navarixin | Experimental | Drug: Navarixin, Drug: PlaceboMatching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Man or woman 18 to 65 years of age of any race.
- Has mild, stable, allergic asthma as defined by American Thoracic Society criteria.
- Has history of episodic wheezing and shortness of breath.
- Has Forced Expiratory Volume in 1 second (FEV1) of at least 70% of predicted at Screening and within 10% of preallergen screening value at both baselines.
- Has positive methacholine challenge at Screening. Methacholine challenges are considered positive if decreases of at least 20% in the FEV1 occur at a concentration of less than or equal to 16 mg/mL.
Key exclusion criteria (11 listed)
- Has had a diagnosis of chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis) other than mild allergic asthma, or has a history of having been intubated.
- Has had a worsening of a respiratory tract infection within 4 weeks before Screening.
- Has had any clinically significant abnormality; history of clinically significant hypotensive episodes of fainting, dizziness, or lightheadedness; history or symptoms of cardiovascular disease; significant neurologic disease; or hematologic abnormality, including coagulopathy; or has a medication regimen or clinically relevant medical condition other than asthma that may interfere with the effect of study medication.
- Had a peripheral blood neutrophil (PBN) count of <3 × 10^9/L at the Screening Visit.
- Has an allergy/sensitivity to the study drug or its excipients.
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 |
|---|---|---|
| NavarixinAlso: SCH 52712330 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 | Drug | Navarixin → Placebo, Placebo → Navarixin |
| PlaceboMatching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 | Drug | Navarixin → Placebo, Placebo → Navarixin |
Primary outcome
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and between 3 and 7 hours after allergen challenge
This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
12 secondary outcomes
Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin
Time frame: Baseline and between 3 and 7 hours after allergen challenge
Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge
Time frame: Baseline and 24 hours after allergen challenge
Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and between 0 to 2 hours after allergen challenge
Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin
Time frame: Baseline and between 0 to 2 hours after allergen challenge
Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin
Time frame: Baseline and 7 and 24 hours after allergen challenge
Number of Participants With an Adverse Event (AE)
Time frame: Up to 48 days
Number of Participants Discontinued From the Study Because of an Adverse Event
Time frame: Up to 48 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navarixin in people with Asthma, run by Merck Sharp & Dohme LLC.
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 16 inclusion and 11 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 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 6 Oct 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?
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin (time frame: Baseline and between 3 and 7 hours after allergen challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2019.