Healthy Volunteers and AsthmaPhase 1NCT01704040
A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16
A Phase 1 study testing CNTO 3157 (healthy participants), CNTO 3157 (asthmatic patients) and HRV-16 in people with Healthy Volunteers and Asthma, run by Janssen Research & Development, LLC at 13 sites in 6 countries.
Trial summary
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers and Asthma
- What is being tested?
- CNTO 3157 (healthy participants), CNTO 3157 (asthmatic patients) and HRV-16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Oct 2012to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understanding of the study and a signed informed consent form before any study-related procedures
- Willing and able to adhere to the restrictions specified in the protocol
- Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN
- Part 1 (healthy participants):
- a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive
- b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2
Show all 10Show fewer
- Part 2:
- a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2
- b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2
- c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2
Who cannot join
- Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation
- At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual
- Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1
- Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study
- Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1
- Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator
Show all 10Show fewer
- Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma
- Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1
- Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids
- Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United Kingdom4 sites
Study site
Belfast
Study site
Dundee
Study site
London
Study site
Manchester
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
Read the detailed description
This is a two-part, randomized (participants are assigned to treatment by chance), double-blind (participants and investigators do not know what study agent is being administered), placebo-controlled study. A placebo appears identical to a study agent, has no active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1, following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract infection, due to inoculation with HRV 16, will be assessed in healthy participants for safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when the last participant completes the last visit (Week 11) in Part 2.
- Conditions
- Healthy Volunteers and Asthma
- Being tested
- CNTO 3157 (healthy participants), Placebo (healthy participants), CNTO 3157 (asthmatic patients), Placebo (asthmatic patients), HRV-16
- Keywords
- Healthy volunteers and asthma, CNTO 3157, Rhinovirus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 3157 (healthy participants)Drug
CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).
Placebo (healthy participants)Drug
Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
CNTO 3157 (asthmatic patients)Drug
CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
Placebo (asthmatic patients)Drug
Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
HRV-16Other
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Healthy participants (CNTO 3157 + HRV-16) | Experimental | Not described Receives: Drug: CNTO 3157 (healthy participants); Other: HRV-16 |
| Part 1: Healthy participants (placebo + HRV-16) | Placebo comparator | Not described Receives: Drug: Placebo (healthy participants); Other: HRV-16 |
| Part 2: Asthmatic patients (CNTO 3157 + HRV-16) | Experimental | Not described Receives: Drug: CNTO 3157 (asthmatic patients); Other: HRV-16 |
| Part 2: Asthmatic patients (placebo + HRV-16) | Placebo comparator | Not described Receives: Drug: Placebo (asthmatic patients); Other: HRV-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
Measured: Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
Secondary outcomes (27)
Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
Cold symptoms is rated using a 5 point scale (0=none and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.
Measured: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in Cold and Chest Symptom Scale
Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.
Measured: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)
Measured: Up to 10 days after inoculation with HRV-16
AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
Measured: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
Measured: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator percent predicted FEV1
Measured: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
Measured: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)
Measured: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator FEV1/FVC
Measured: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in average total asthma symptom diary score
Measured: Up to 10 days after inoculation with HRV-16
Change from baseline in Asthma Control Questionnaire (ACQ)
ACQ is an instrument designed to evaluate asthma control. Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score. Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale. Higher scores reflect poorer control.
Measured: Up to 10 days after inoculation with HRV-16
Change from baseline in Cold Symptom Assessment Score
Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff. The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness. Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.
Measured: Up to 11 weeks
Change from baseline in Cold and Chest Symptom Scale
The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score.
Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness.
Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.
Measured: Up to 11 weeks
Change from baseline in log-transformed FENO over time
Measured: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1
Measured: Up to 11 weeks
Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
Measured: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FVC
Measured: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
Measured: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
Measured: Up to 11 weeks
Change from baseline in morning/evening PEFR over time
Measured: Up to 11 weeks
Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period.
Measured: Up to Day 22
Change from baseline in average total asthma symptom diary score
Measured: Up to 11 weeks
Change from baseline in average number of nocturnal awakenings
Measured: Up to 11 weeks
Change from baseline in average rescue medication use over time
Measured: Up to 11 weeks
Number of symptom-free days
Measured: Up to 10 days after inoculation with HRV-16
The maximum decrease from baseline in the prebronchodilator FEV1 measurements
Measured: Up to 10 days after inoculation with HRV-16
Time to the maximum decrease relative to baseline in prebronchodilator FEV1
Measured: Up to 10 days after inoculation with HRV-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers and AsthmaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704040
- Sponsor's protocol ID
- CR100889
- Other IDs
- CNTO3157ASH1002, 2011-005369-19
- Status last verified
- Dec 2014
- First submitted
- 8 Oct 2012
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silkoff PE, Flavin S, Gordon R, Loza MJ, Sterk PJ, Lutter R, Diamant Z, Turner RB, Lipworth BJ, Proud D, Singh D, Eich A, Backer V, Gern JE, Herzmann C, Halperin SA, Mensinga TT, Del Vecchio AM, Branigan P, San Mateo L, Baribaud F, Barnathan ES, Johnston SL. Toll-like receptor 3 blockade in rhinovirus-induced experimental asthma exacerbations: A randomized controlled study. J Allergy Clin Immunol. 2018 Apr;141(4):1220-1230. doi: 10.1016/j.jaci.2017.06.027. Epub 2017 Jul 20.
PubMed 28734844
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16
- ClinicalTrials.gov ID
- NCT01704040
- Acronym / sponsor ID
- CR100889
- Conditions
- Healthy Volunteers and Asthma
- Keywords
- Healthy volunteers and asthma, CNTO 3157, Rhinovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
Detailed description
This is a two-part, randomized (participants are assigned to treatment by chance), double-blind (participants and investigators do not know what study agent is being administered), placebo-controlled study. A placebo appears identical to a study agent, has no active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1, following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract infection, due to inoculation with HRV 16, will be assessed in healthy participants for safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when the last participant completes the last visit (Week 11) in Part 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Healthy participants (CNTO 3157 + HRV-16) | Experimental | Drug: CNTO 3157 (healthy participants), Other: HRV-16 |
| Part 1: Healthy participants (placebo + HRV-16) | Placebo comparator | Drug: Placebo (healthy participants), Other: HRV-16 |
| Part 2: Asthmatic patients (CNTO 3157 + HRV-16) | Experimental | Drug: CNTO 3157 (asthmatic patients), Other: HRV-16 |
| Part 2: Asthmatic patients (placebo + HRV-16) | Placebo comparator | Drug: Placebo (asthmatic patients), Other: HRV-16 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understanding of the study and a signed informed consent form before any study-related procedures
- Willing and able to adhere to the restrictions specified in the protocol
- Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN
- Part 1 (healthy participants):
- a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive
Key exclusion criteria (10 listed)
- Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation
- At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual
- Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1
- Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study
- Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1
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 |
|---|---|---|
| CNTO 3157 (healthy participants)CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16). | Drug | Part 1: Healthy participants (CNTO 3157 + HRV-16) |
| Placebo (healthy participants)Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16. | Drug | Part 1: Healthy participants (placebo + HRV-16) |
| CNTO 3157 (asthmatic patients)CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. | Drug | Part 2: Asthmatic patients (CNTO 3157 + HRV-16) |
| Placebo (asthmatic patients)Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. | Drug | Part 2: Asthmatic patients (placebo + HRV-16) |
| HRV-16Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris. | Other | Part 1: Healthy participants (CNTO 3157 + HRV-16), Part 1: Healthy participants (placebo + HRV-16), Part 2: Asthmatic patients (CNTO 3157 + HRV-16), Part 2: Asthmatic patients (placebo + HRV-16) |
Primary outcome
The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
Time frame: Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
27 secondary outcomes
Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
Time frame: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in Cold and Chest Symptom Scale
Time frame: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)
Time frame: Up to 10 days after inoculation with HRV-16
AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
Time frame: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
Time frame: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator percent predicted FEV1
Time frame: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
Time frame: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)
Time frame: Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator FEV1/FVC
Time frame: Up to 10 days after inoculation with HRV-16
AUC of change from baseline in average total asthma symptom diary score
Time frame: Up to 10 days after inoculation with HRV-16
Change from baseline in Asthma Control Questionnaire (ACQ)
Time frame: Up to 10 days after inoculation with HRV-16
Change from baseline in Cold Symptom Assessment Score
Time frame: Up to 11 weeks
Change from baseline in Cold and Chest Symptom Scale
Time frame: Up to 11 weeks
Change from baseline in log-transformed FENO over time
Time frame: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1
Time frame: Up to 11 weeks
Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
Time frame: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FVC
Time frame: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
Time frame: Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
Time frame: Up to 11 weeks
Change from baseline in morning/evening PEFR over time
Time frame: Up to 11 weeks
Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
Time frame: Up to Day 22
Change from baseline in average total asthma symptom diary score
Time frame: Up to 11 weeks
Change from baseline in average number of nocturnal awakenings
Time frame: Up to 11 weeks
Change from baseline in average rescue medication use over time
Time frame: Up to 11 weeks
Number of symptom-free days
Time frame: Up to 10 days after inoculation with HRV-16
The maximum decrease from baseline in the prebronchodilator FEV1 measurements
Time frame: Up to 10 days after inoculation with HRV-16
Time to the maximum decrease relative to baseline in prebronchodilator FEV1
Time frame: Up to 10 days after inoculation with HRV-16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Derived from this study: PubMed 28734844Silkoff PE, Flavin S, Gordon R, Loza MJ, Sterk PJ, Lutter R, Diamant Z, Turner RB, Lipworth BJ, Proud D, Singh D, Eich A, Backer V, Gern JE, Herzmann C, Halperin SA, Mensinga TT, Del Vecchio AM, Branigan P, San Mateo L, Baribaud F, Barnathan ES, Johnston SL. Toll-like receptor 3 blockade in rhinovirus-induced experimental asthma exacerbations: A randomized controlled study. J Allergy Clin Immunol. 2018 Apr;141(4):1220-1230. doi: 10.1016/j.jaci.2017.06.027. Epub 2017 Jul 20.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 3157 (healthy participants), CNTO 3157 (asthmatic patients) and HRV-16 in people with Healthy Volunteers and Asthma, run by Janssen Research & Development, LLC at 13 sites in 6 countries.
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 10 inclusion and 10 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 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Canada, Denmark, Germany, Netherlands and 1 more country. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2) (time frame: Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)). 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 NCT01704040, 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 12 Dec 2014.