Rhinitis, Allergic, SeasonalPhase 1NCT01008397
Study of AHIST in Seasonal Allergic Rhinitis Patients
A Phase 1 study testing AHIST NDC#58407-012-01 in people with Rhinitis, Allergic, Seasonal, run by Magna Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Objectives: A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours. Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- AHIST NDC#58407-012-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females of any ethnic group between 18 and 60 years of age.
- History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.
- Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip.
- Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.
- Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient medical history.
Who cannot join
- Pregnancy or lactation.
- Immunotherapy unless at stable maintenance dose.
- Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- Alcohol dependence.
- Use of any other investigational drug in the previous month.
- Subjects presenting with asthma requiring corticosteroid treatment.
- Subjects with multiple drug allergies.
- Subjects known to have an idiosyncratic reaction to any of the ingredients in AHIST.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215
About this study
Official title: Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
Objectives:
- To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours.
Read more
Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data);
- To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval.
Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST;
- Report any side effects or adverse drug reactions and rate the severity of any incidence.
Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients-drowsiness.
Read the detailed description
This Phase 1 clinical trial will be a single dose pharmacokinetics study comprised of 21 individuals with five blood draws over a 12 hour period. Additionally, subjects will subjectively score symptom relief and report any side effects from the single dose of AHIST. Schulman Associates Institutional Review Board (Cincinnati, OH) will approve the study protocol and statement of informed consent. Each study participant will give written informed consent (See Attachment A). Safety will be assured through close observation and physical examination of subjects before, during and at study conclusion. This interventional study will be conducted during the spring allergy season of 2010.
MAGNA plans to show that chlorpheniramine tannate is a safe and effective B.I.D. drug treatment regimen, "indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]."
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- AHIST NDC#58407-012-01
- Keywords
- Rhinitis, Allergic, Seasonal
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHIST NDC#58407-012-01Drug
Oral tablet containing chlorpheniramine tannate 12mg.
| Study group | Role | What they receive |
|---|---|---|
| AHIST for seasonal allergic rhinitis | Experimental | AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate. Receives: Drug: AHIST NDC#58407-012-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.
Measured: April 2011
Secondary outcomes (1)
To report any side effects or adverse drug reactions and rate the severity of incidence.
Measured: April 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startApr 2011
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
Why it stopped: Manufacturer unable to produce
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen J Pollard, MD, Principal investigator, Family Allergy and Asthma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008397
- Sponsor's protocol ID
- AHIST IND
- Status last verified
- Feb 2011
- First submitted
- 27 Oct 2009
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of AHIST in Seasonal Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT01008397
- Acronym / sponsor ID
- AHIST IND
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer unable to produce
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Magna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 5 Nov 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.
Objectives:
- To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours.
Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data);
- To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval.
Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST;
- Report any side effects or adverse drug reactions and rate the severity of any incidence.
Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients-drowsiness.
Detailed description
This Phase 1 clinical trial will be a single dose pharmacokinetics study comprised of 21 individuals with five blood draws over a 12 hour period. Additionally, subjects will subjectively score symptom relief and report any side effects from the single dose of AHIST. Schulman Associates Institutional Review Board (Cincinnati, OH) will approve the study protocol and statement of informed consent. Each study participant will give written informed consent (See Attachment A). Safety will be assured through close observation and physical examination of subjects before, during and at study conclusion. This interventional study will be conducted during the spring allergy season of 2010.
MAGNA plans to show that chlorpheniramine tannate is a safe and effective B.I.D. drug treatment regimen, "indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHIST for seasonal allergic rhinitis | Experimental | Drug: AHIST NDC#58407-012-01AHIST for SAR: each green tablet contains 12mg chlorpheniramine tannate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and females of any ethnic group between 18 and 60 years of age.
- History of moderate to severe Seasonal Allergic Rhinitis (SAR) for at least two years.
- Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms ("S5") that are the focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post nasal drip.
- Prior to study drug administration, subjects' good health will be confirmed by medical history, physical examination, and urine dip pregnancy test.
- Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established patient medical history.
Key exclusion criteria (8 listed)
- Pregnancy or lactation.
- Immunotherapy unless at stable maintenance dose.
- Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- Alcohol dependence.
- Use of any other investigational drug in the previous month.
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 |
|---|---|---|
| AHIST NDC#58407-012-01Oral tablet containing chlorpheniramine tannate 12mg. | Drug | AHIST for seasonal allergic rhinitis |
Primary outcome
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours.
Time frame: April 2011
1 secondary outcome
To report any side effects or adverse drug reactions and rate the severity of incidence.
Time frame: April 2011
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 6 Mar 2014.
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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.
Stephen J Pollard, MD principal investigator
Family Allergy and Asthma Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AHIST NDC#58407-012-01 in people with Rhinitis, Allergic, Seasonal, run by Magna Pharmaceuticals, Inc. 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 5 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: withdrawn, as of the sponsor's last update on 6 Mar 2014. 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. 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 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?
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredient in AHIST over the dosage interval period of 12 hours. (time frame: April 2011). 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 6 Mar 2014.