Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00932256
Other study ID # STAHIST IND 105781
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00851344 - Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo Phase 2
Completed NCT00501527 - Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense Phase 2
Completed NCT00537355 - An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00422149 - Twin SUBLIVAC® Grasses Clinical Efficacy Study Phase 3
Completed NCT00542607 - Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis Phase 4
Completed NCT00605852 - Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects Phase 1
Active, not recruiting NCT05960266 - Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study Early Phase 1
Completed NCT02256553 - Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006) Phase 4
Completed NCT01007721 - Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season Phase 2
Completed NCT00901914 - Study of rBet v1 Tablets Phase 2
Completed NCT00384475 - A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413) Phase 3
Completed NCT00135629 - Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever Phase 3
Completed NCT00839189 - Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults Phase 1
Completed NCT04687059 - An Exploratory Study of PQ Grass 27600 SU Phase 2/Phase 3
Completed NCT00889460 - Safety and Tolerability Study of rBet v1 SLIT Tablets Phase 1
Completed NCT00396149 - Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 Phase 1
Completed NCT00127647 - An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327) Phase 3
Completed NCT00659594 - Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406) Phase 3
Completed NCT01480271 - An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics. Phase 1