WheezingPhase 3NCT00628303
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
A Phase 3 study testing Motavizumab in people with Wheezing, run by MedImmune LLC.
Trial summary
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Wheezing
- What is being tested?
- Motavizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 3
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female infants born at 32 \& 1/7 - 35 \& 0/7 weeks GA, determined according to available medical records
- Chronological age of <6 months of age at randomization
- In good health, in the opinion of the investigator
- Not more than one of the following AAP-defined risk factors:
- Childcare attendance
- School-aged siblings
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- Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
- Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
- Written informed consent obtained from the subject's parent(s) or legal guardian
Who cannot join
- Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
- Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
- Congenital abnormalities of the airways
- Severe neuromuscular disease, as determined by the investigator
- Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
- Eligible for prophylaxis based on local medical standards and guidelines at participating sites
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- Known immunodeficiency
- Previous or current diagnosis of an upper or lower respiratory infection by a medical professional
- Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses
- Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)
- Any illness or condition that would preclude long-term survival
- Participation in a trial or an investigational agent for RSV prophylaxis or therapy
- Inability to be followed through their 3rd birthday
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.
Read the detailed description
The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.
- Conditions
- Wheezing
- Being tested
- Motavizumab, Placebo
- Keywords
- Good health
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotavizumabBiological
Also called MEDI-524
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
PlaceboOther
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Motavizumab Receives: Biological: Motavizumab |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of serious early childhood wheezing episodes
Measured: Between 2nd and 3rd birthdays
Secondary outcomes (3)
Frequency of medically-attended lower respiratory tract wheezing events
Measured: During 2nd and 3rd birthday
Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age
Measured: From randomization through 3 yrs.
Incidence of serious RSV disease
Measured: Through Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Study never officially opened for enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628303
- Sponsor's protocol ID
- MI-CP169
- Status last verified
- Jul 2012
- First submitted
- 20 Feb 2008
- Last updated
- 1 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants
- ClinicalTrials.gov ID
- NCT00628303
- Acronym / sponsor ID
- MI-CP169
- Conditions
- Wheezing
- Keywords
- Good health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never officially opened for enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Mar 2008 (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 primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.
Detailed description
The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MotavizumabMotavizumab |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female infants born at 32 \& 1/7 - 35 \& 0/7 weeks GA, determined according to available medical records
- Chronological age of <6 months of age at randomization
- In good health, in the opinion of the investigator
- Not more than one of the following AAP-defined risk factors:
- Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
Key exclusion criteria (13 listed)
- Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
- Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
- Congenital abnormalities of the airways
- Severe neuromuscular disease, as determined by the investigator
- Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
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 |
|---|---|---|
| MotavizumabAlso: MEDI-52415 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections | Biological | 1 |
| Placebo15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections | Other | 2 |
Primary outcome
The incidence of serious early childhood wheezing episodes
Time frame: Between 2nd and 3rd birthdays
3 secondary outcomes
Frequency of medically-attended lower respiratory tract wheezing events
Time frame: During 2nd and 3rd birthday
Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age
Time frame: From randomization through 3 yrs.
Incidence of serious RSV disease
Time frame: Through Day 150
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motavizumab in people with Wheezing, run by MedImmune 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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 1 Aug 2012. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 incidence of serious early childhood wheezing episodes (time frame: Between 2nd and 3rd birthdays). 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 1 Aug 2012.