Allergic ReactionsPhase 1NCT00894634
Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents
A Phase 1 study testing Brompheniramine maleate in people with Allergic Reactions, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Allergic Reactions
- What is being tested?
- Brompheniramine maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2009to 26 Apr 2009
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females between 2 to less than 18 yrs of age with a minimum weight of 24 pounds and within the 5th and 95th percentiles in height and weight, and BMI based on age and gender
- Symptomatic or asymptomatic children/adolescents as follows:
- A prior diagnosis of allergic rhinitis and either symptomatic or asymptomatic at the time of entry in the study; or * Symptoms of an acute URI; or
- No symptoms of an acute URI, but at risk for developing an acute URI as evidenced by the following frequency, crowding, and exposure criteria:
- Frequency: a history of frequent URIs defined as greater than 6 infections/yr for children aged 2 to less than 6 yrs and as greater than 4 infections per year for adolescents aged 6 to less than 18 yrs;
- Crowding: living in a home with greater than 4 persons, or sleeping in the same bedroom with greater than 3 persons;
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- Exposure: the presence of another family member in the household who is ill with a URI, or a child in the family that is attending preschool, or attending school with greater than 6 children in the class;
- Except for allergic rhinitis or a URI, children/adolescents are in normal physical health (i.e., no clinically significant systemic disease) as judged by the Investigator upon physical examination of the subject;
- Subjects do not require concomitant medication except for low-dose inhaled glucocorticoids for allergic rhinitis or mild concomitant asthma, if dose is stabilized before entry in the study (i.e., dose is not changed for one month prior to or during the study), and inhaled short-acting beta-2 adrenergic agonists for concomitant asthma, as needed;
- Post menarchal females must be using a reliable method of contraception (i.e., oral, transdermal, injectable or implanted contraceptives, IUD, cervical cap, diaphragm, condom, abstinence, or surgical sterility).
Who cannot join
- The child/adolescent weighs less than 24 pounds or is below the 5th or above the 95th percentiles in physical growth characteristics (i.e., height and weight), and BMI based on age and gender;
- Inability to swallow the medication;
- Eaten within 2 hours prior to dosing;
- A known hypersensitivity to BROM, any other antihistamine, or EMLA cream;
- Systolic and/or diastolic blood pressure at or above the 95th percentile based on gender, and age and height percentiles. (Note: If a subject with no history of hypertension has a blood pressure reading at or above the 95th percentile, the subject will be allowed to rest for 15 minutes and the blood pressure measurement repeated. Up to 3 consecutive measurements at approximately 5 min intervals will be allowed. Subjects who continue to have systolic and/or diastolic blood pressure readings at or above the 95th percentile will be excluded from the study);
- History of melena or any hepatic, renal, endocrine (e.g., diabetes, thyroid disorder), cardiac, neurological, psychiatric, gastrointestinal, hematological or metabolic disorder deemed to be clinically significant by the Investigator;
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- Any serious medical condition or medical history felt by the Investigator to place them at increased risk;
- The child is diagnosed with anemia or has a red blood cell count or hemoglobin level outside of normal range as evidenced by baseline hematology assessment;
- Asthma symptoms at the time of entry in the study or requires medication other than allowed under Inclusion Criterion d;
- Failure to comply with appropriate washout periods for any H-1 receptor antagonist treatment before and during the study, i.e., no use within 7 days of entering the study or at any time during the study, and no use of astemizole within the preceding 3 calendar months;
- Other than described in Exclusion Criterion i, use of any medication 72 hours prior to dosing;
- A history of drug, alcohol, or tobacco abuse (older children and adolescents), a history of Hepatitis B, a previous positive test for Hepatitis B surface antigen, or a previous positive Hepatitis C antibody;
- A history of HIV infection or previous demonstration of HIV antibodies;
- Female subjects who have experienced menarche and have a positive urine pregnancy test;
- Parent/guardian/subject judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
- Have taken an investigational drug within 30 days prior to entering the study or have already participated in the trial;
- Relative of the Sponsor, Investigator, or any personnel of the study site who are directly involved with the study.
About this study
Official title: A Single-Dose, Open-Label, Pharmacokinetic Study of Brompheniramine Maleate Liquid in Children and Adolescents
The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.
- Conditions
- Allergic Reactions
- Being tested
- Brompheniramine maleate
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brompheniramine maleateDrug
| Study group | Role | What they receive |
|---|---|---|
| Brompheniramine maleate | Experimental | Brompheniramine maleate oral solution 1 mg/5 mL, single dose Receives: Drug: Brompheniramine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log transformed values of AUCL and Cmax
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study start21 Mar 2009
- Primary completion26 Apr 2009
- Study completion26 Apr 2009
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 Allergic ReactionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894634
- Sponsor's protocol ID
- BF-08-06
- Status last verified
- Oct 2020
- First submitted
- 5 May 2009
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pathirana S, Jayawardena S, Meeves S, Thompson GA. Brompheniramine and Chlorpheniramine Pharmacokinetics Following Single-Dose Oral Administration in Children Aged 2 to 17 Years. J Clin Pharmacol. 2018 Apr;58(4):494-503. doi: 10.1002/jcph.1037. Epub 2017 Nov 14.
PubMed 29136286
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Pharmacokinetic Study of Brompheniramine Maleate Liquid in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00894634
- Acronym / sponsor ID
- BF-08-06
- Conditions
- Allergic Reactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2009
- Primary completion
- 26 Apr 2009 (actual)
- Study completion
- 26 Apr 2009 (actual)
- First posted
- 7 May 2009 (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 objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brompheniramine maleate | Experimental | Drug: Brompheniramine maleateBrompheniramine maleate oral solution 1 mg/5 mL, single dose |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Males or females between 2 to less than 18 yrs of age with a minimum weight of 24 pounds and within the 5th and 95th percentiles in height and weight, and BMI based on age and gender
- Symptomatic or asymptomatic children/adolescents as follows:
- Except for allergic rhinitis or a URI, children/adolescents are in normal physical health (i.e., no clinically significant systemic disease) as judged by the Investigator upon physical examination of the subject;
- Subjects do not require concomitant medication except for low-dose inhaled glucocorticoids for allergic rhinitis or mild concomitant asthma, if dose is stabilized before entry in the study (i.e., dose is not changed for one month prior to or during the study), and inhaled short-acting beta-2 adrenergic agonists for concomitant asthma, as needed;
- Post menarchal females must be using a reliable method of contraception (i.e., oral, transdermal, injectable or implanted contraceptives, IUD, cervical cap, diaphragm, condom, abstinence, or surgical sterility).
Key exclusion criteria (17 listed)
- The child/adolescent weighs less than 24 pounds or is below the 5th or above the 95th percentiles in physical growth characteristics (i.e., height and weight), and BMI based on age and gender;
- Inability to swallow the medication;
- Eaten within 2 hours prior to dosing;
- A known hypersensitivity to BROM, any other antihistamine, or EMLA cream;
- Systolic and/or diastolic blood pressure at or above the 95th percentile based on gender, and age and height percentiles. (Note: If a subject with no history of hypertension has a blood pressure reading at or above the 95th percentile, the subject will be allowed to rest for 15 minutes and the blood pressure measurement repeated. Up to 3 consecutive measurements at approximately 5 min intervals will be allowed. Subjects who continue to have systolic and/or diastolic blood pressure readings at or above the 95th percentile will be excluded from the study);
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 |
|---|---|---|
| Brompheniramine maleate | Drug | Brompheniramine maleate |
Primary outcome
Log transformed values of AUCL and Cmax
Time frame: 72 hours
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 23 Oct 2020.
- Derived from this study: PubMed 29136286Pathirana S, Jayawardena S, Meeves S, Thompson GA. Brompheniramine and Chlorpheniramine Pharmacokinetics Following Single-Dose Oral Administration in Children Aged 2 to 17 Years. J Clin Pharmacol. 2018 Apr;58(4):494-503. doi: 10.1002/jcph.1037. Epub 2017 Nov 14.
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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 Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brompheniramine maleate in people with Allergic Reactions, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 17 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 23 Oct 2020. 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 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?
Log transformed values of AUCL and Cmax (time frame: 72 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 NCT00894634, 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 23 Oct 2020.