Rhinitis, AllergicPhase 2NCT02722083
Exploratory Study for Allergy Relief Onset
A Phase 2 study testing Chlorpheniramine maleate (BAY X002134) in people with Rhinitis, Allergic, run by Bayer at 1 site in United States.
Trial summary
The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Chlorpheniramine maleate (BAY X002134)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2016to 13 Jul 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;
- Self-reported to have seasonal allergic rhinitis for at least 2 years prior
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal > 4mm larger than the diluent within the previous 12 months
- Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;
- Body Mass Index (BMI) in the range of 18 to 30 kg/m2
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP administration on Day 1 and Day 7 ± 1 day. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy
Who cannot join
- Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
- Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
- Self-reported non-responders (lack of therapeutic effect) to antihistamines
- Administration of epinephrine is contra-indicated;
- Current use of oral steroids, including prednisone and prednisolone;
- Females who are pregnant or lactating
- A history of anaphylaxis to ragweed allergen
- Subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; At the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomized, Placebo Controlled, Crossover Pilot Study to Evaluate the Onset of Action of an Antihistamine in Subjects Following Allergen Exposure in an Allergen Chamber
The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.
- Conditions
- Rhinitis, Allergic
- Being tested
- Chlorpheniramine maleate (BAY X002134), Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorpheniramine maleate (BAY X002134)Drug
4 mg tablet, single dose, orally
PlaceboDrug
placebo tablet, single dose, orally
| Study group | Role | What they receive |
|---|---|---|
| BAY X002134 | Experimental | Subjects will be given BAY X002134 Receives: Drug: Chlorpheniramine maleate (BAY X002134) |
| Placebo | Placebo comparator | Subjects will be given a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)
Measured: 4 hours
Secondary outcomes (1)
Number of patients with adverse events as a measure of safety
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start7 May 2016
- Primary completion27 May 2016
- Study completion13 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722083
- Sponsor's protocol ID
- 18573
- Status last verified
- Dec 2018
- First submitted
- 23 Mar 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Placebo Controlled, Crossover Pilot Study to Evaluate the Onset of Action of an Antihistamine in Subjects Following Allergen Exposure in an Allergen Chamber
- ClinicalTrials.gov ID
- NCT02722083
- Acronym / sponsor ID
- 18573
- Conditions
- Rhinitis, Allergic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 May 2016 (actual)
- Primary completion
- 27 May 2016 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 29 Mar 2016 (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 purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY X002134 | Experimental | Drug: Chlorpheniramine maleate (BAY X002134)Subjects will be given BAY X002134 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be given a placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;
- Self-reported to have seasonal allergic rhinitis for at least 2 years prior
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal > 4mm larger than the diluent within the previous 12 months
- Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;
- Body Mass Index (BMI) in the range of 18 to 30 kg/m2
Key exclusion criteria (8 listed)
- Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
- Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
- Self-reported non-responders (lack of therapeutic effect) to antihistamines
- Administration of epinephrine is contra-indicated;
- Current use of oral steroids, including prednisone and prednisolone;
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 |
|---|---|---|
| Chlorpheniramine maleate (BAY X002134)4 mg tablet, single dose, orally | Drug | BAY X002134 |
| Placeboplacebo tablet, single dose, orally | Drug | Placebo |
Primary outcome
The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)
Time frame: 4 hours
1 secondary outcome
Number of patients with adverse events as a measure of safety
Time frame: 3 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorpheniramine maleate (BAY X002134) in people with Rhinitis, Allergic, run by Bayer at 1 site 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: stopped early, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
The study was stopped early. Results are not available in the source record.
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 time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS) (time frame: 4 hours). 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 12 Dec 2018.