Rhinitis, Allergic, SeasonalPhase 1NCT00932256
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
A Phase 1 study testing STAHIST NDC #58407-536-01 in people with Rhinitis, Allergic, Seasonal, run by Magna Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- STAHIST NDC #58407-536-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2010
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Males and females of any ethnic group between the ages of 18 and 60 years of age.
- History of moderate to severe SAR for at least one year.
- Subjects' symptoms will include the five symptoms ("S5") that are the focus of this study:
- nasal congestion;
- rhinorrhea;
- nasal itching;
Show all 10Show fewer
- sneezing;
- post nasal drip.
- Prior to study subjects' good health will be confirmed by medical history and physical examination.
- Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established 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 STAHIST.
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: STAHIST IND 105781 Phase 1 Clinical Trial
MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.
Read the detailed description
No procedure will be performed until Informed Consent has been obtained. Inclusion and exclusion criteria will be verified. Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours, second generation antihistamines and Singulair for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid medications for two weeks. Use of these drugs will not be allowed during the study.
Blood samples will be drawn at specific time points: baseline fasting blood draw just before 7AM, then at 9 AM, 11AM, 3PM, and 7PM. A single oral dose of STAHIST will be administered at 7AM.
During the study a diary of the five study symptoms (S5 Diary) will be scored hourly over the 12-hour period as follows: 0 none, 1 mild, 2 moderate, 3 severe. The S5 symptoms are 1. Nasal Congestion (Stuffiness); 2. Sneezing; 3. Rhinorrhea (runny nose); 4. Nasal Itching; 5. Post-nasal drip. Post nasal drip is defined for the patient as "you can feel accumulated mucus dripping down the back of your throat from your sinuses, also possibly including a tickly cough or sore throat due to this sensation of mucus."
Side effects or adverse drug reactions will be scored if they occur and hourly as 1 mild, 2 moderate, and 3 severe. Any adverse events will be recorded. Any subject who is not able or who is unwilling to continue keeping a diary or participate in blood draws will be permitted to withdraw from the study. Safety will be assured by the frequent visible assessment and questioning of subjects as well as monitoring of subjects' vital signs by Dr. Pollard and his nursing staff. Subjects will remain in the clinic during the 12-hour dosage interval. Thereafter, Dr. Pollard and selected staff will be on call 24 hours to answer any subject phone calls.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- STAHIST NDC #58407-536-01
- 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.
STAHIST NDC #58407-536-01Drug
Also called STAHIST NDC#58407-536-01
Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
| Study group | Role | What they receive |
|---|---|---|
| STAHIST for seasonal allergic rhinitis | Experimental | STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg Receives: Drug: STAHIST NDC #58407-536-01 |
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 ingredients in STAHIST over the dosage interval period of 12 hours.
Measured: August 2009
Secondary outcomes (1)
To report any side effects or adverse drug reactions and rate the severity of incidence.
Measured: August 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionDec 2010
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen J Pollard, MD, Principal investigator, Family Allergy and Asthma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932256
- Sponsor's protocol ID
- STAHIST IND 105781
- Status last verified
- Dec 2010
- First submitted
- 30 Jun 2009
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. No abstract available.
PubMed 5640510
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAHIST IND 105781 Phase 1 Clinical Trial
- ClinicalTrials.gov ID
- NCT00932256
- Acronym / sponsor ID
- STAHIST IND 105781
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Magna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jul 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.
MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.
Detailed description
No procedure will be performed until Informed Consent has been obtained. Inclusion and exclusion criteria will be verified. Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours, second generation antihistamines and Singulair for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid medications for two weeks. Use of these drugs will not be allowed during the study.
Blood samples will be drawn at specific time points: baseline fasting blood draw just before 7AM, then at 9 AM, 11AM, 3PM, and 7PM. A single oral dose of STAHIST will be administered at 7AM.
During the study a diary of the five study symptoms (S5 Diary) will be scored hourly over the 12-hour period as follows: 0 none, 1 mild, 2 moderate, 3 severe. The S5 symptoms are 1. Nasal Congestion (Stuffiness); 2. Sneezing; 3. Rhinorrhea (runny nose); 4. Nasal Itching; 5. Post-nasal drip. Post nasal drip is defined for the patient as "you can feel accumulated mucus dripping down the back of your throat from your sinuses, also possibly including a tickly cough or sore throat due to this sensation of mucus."
Side effects or adverse drug reactions will be scored if they occur and hourly as 1 mild, 2 moderate, and 3 severe. Any adverse events will be recorded. Any subject who is not able or who is unwilling to continue keeping a diary or participate in blood draws will be permitted to withdraw from the study. Safety will be assured by the frequent visible assessment and questioning of subjects as well as monitoring of subjects' vital signs by Dr. Pollard and his nursing staff. Subjects will remain in the clinic during the 12-hour dosage interval. Thereafter, Dr. Pollard and selected staff will be on call 24 hours to answer any subject phone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAHIST for seasonal allergic rhinitis | Experimental | Drug: STAHIST NDC #58407-536-01STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males and females of any ethnic group between the ages of 18 and 60 years of age.
- History of moderate to severe SAR for at least one year.
- Subjects' symptoms will include the five symptoms ("S5") that are the focus of this study:
- Prior to study subjects' good health will be confirmed by medical history and physical examination.
- Allergic hypersensitivity will be confirmed by an appropriate test as deemed necessary by the physician or well established 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 |
|---|---|---|
| STAHIST NDC #58407-536-01Also: STAHIST NDC#58407-536-01Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID. | Drug | STAHIST for seasonal allergic rhinitis |
Primary outcome
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours.
Time frame: August 2009
1 secondary outcome
To report any side effects or adverse drug reactions and rate the severity of incidence.
Time frame: August 2009
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 8 Dec 2010.
- Results publication: PubMed 5640510Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. No abstract available.
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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 STAHIST NDC #58407-536-01 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 10 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: finished, as of the sponsor's last update on 8 Dec 2010. 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 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?
To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours. (time frame: August 2009). 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 NCT00932256, 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 8 Dec 2010.