Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

STAHIST IND 105781 Phase 1 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932256
• Other study ID #: STAHIST IND 105781
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2009
• Last updated: December 6, 2010
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Magna Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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). 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.

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.

Other known NCT identifiers

• NCT00931658

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• STAHIST NDC #58407-536-01
Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.

Locations

Country	Name	City	State
United States	Family Allergy and Asthma Research Institute	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Magna Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours.		August 2009	Yes
Secondary	To report any side effects or adverse drug reactions and rate the severity of incidence.		August 2009	Yes