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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02318303
Other study ID # GPL/CT/2014/004/II
Secondary ID IND Number: 1231
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2014
Est. completion date February 2015

Study information

Verified date September 2020
Source Glenmark Pharmaceuticals Ltd. India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.


Recruitment information / eligibility

Status Completed
Enrollment 1111
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Key Inclusion Criteria: 1. Aged =12 years and older inclusive of either sex. 2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen 3. A 12-hour reflective TNSS = 8 out of a possible 12 and a congestion score of = 2 for the AM assessment at the Screening Visit (Visit 1). Key Exclusion Criteria: 1. Pregnant or lactating women. 2. Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period. 3. History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa. 4. History of anaphylaxis and/or other severe local reaction(s) to skin testing. 5. History of positive test for HIV, Hepatitis B or Hepatitis C infection. 6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 7. Subjects with an active pulmonary disorder or infection. 8. Subjects with posterior subcapsular cataracts or glaucoma.

Study Design


Intervention

Drug:
GSP 301-1 NS (QD)
GSP 301-1 NS (665 µg olopatadine hydrochloride/50 µg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (BID)
GSP 301-2 NS (665 µg olopatadine hydrochloride/25 µg mometasone furoate) administered as 2 sprays/nostril
GSP 301 Placebo NS
GSP 301 placebo NS administered as 2 sprays/nostril
Olopatadine HCl-1 NS (QD)
Olopatadine HCl-1 NS (665 µg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (BID)
Olopatadine HCl-2 NS (665 µg) administered as 2 sprays/nostril
Mometasone Furoate-1 NS (QD)
Mometasone furoate -1 NS (50 µg) administered as 2 sprays/nostril
Mometasone Furoate-2 NS (BID)
Mometasone furoate-2 NS (25 µg) administered as 2 sprays/nostril

Locations

Country Name City State
United States Glenmark Investigational Site 10 Austin Texas
United States Glenmark Investigational Site 5 Austin Texas
United States Glenmark Investigational Site 6 Austin Texas
United States Glenmark Investigational Site 2 Kerrville Texas
United States Glenmark Investigational Site 7 New Braunfels Texas
United States Glenmark Investigational Site 3 San Antonio Texas
United States Glenmark Investigational Site 4 San Antonio Texas
United States Glenmark Investigational Site 8 San Antonio Texas
United States Glenmark Investigational Site 9 San Antonio Texas
United States Glenmark Investigational Site 1 Waco Texas

Sponsors (1)

Lead Sponsor Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in rTNSS From Baseline to End of Treatment Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.
The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.
The severity scale for each symptom evaluation was defined as follows:
0 = absent (no sign/symptom evident)
1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)
2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])
14 days
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