Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

This study has been completed.
Sponsor:
Information provided by:
Magna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00932256
First received: June 30, 2009
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: STAHIST NDC #58407-536-01
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STAHIST IND 105781 Phase 1 Clinical Trial

Resource links provided by NLM:


Further study details as provided by Magna Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To report any side effects or adverse drug reactions and rate the severity of incidence. [ Time Frame: August 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STAHIST for seasonal allergic rhinitis
STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg
Drug: STAHIST NDC #58407-536-01
Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
Other Name: STAHIST NDC#58407-536-01

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
    • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932256

Locations
United States, Kentucky
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States, 40215
Sponsors and Collaborators
Magna Pharmaceuticals, Inc.
Investigators
Principal Investigator: Stephen J Pollard, MD Family Allergy and Asthma Research Institute
  More Information

Publications:
Responsible Party: Warren P. Lesser, President, MAGNA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00932256     History of Changes
Obsolete Identifiers: NCT00931658
Other Study ID Numbers: STAHIST IND 105781
Study First Received: June 30, 2009
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Magna Pharmaceuticals, Inc.:
Rhinitis, Allergic, Seasonal

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Atropine
Pseudoephedrine
Ephedrine
Chlorpheniramine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014