A Phase 2 interventional study of GSP 301-1 NS (QD) and GSP 301-2 NS (BID) in Seasonal Allergic Rhinitis, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 10 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 2, Interventional, and Treatment
Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's enrollment of 1,111 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Glenmark Pharmaceuticals Ltd. India is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GSP 301 Placebo NS
Drug: GSP 301-1 NS (QD)
Drug: GSP 301-2 NS (BID)
Drug: Olopatadine HCl-1 NS (QD)
Drug: Olopatadine HCl-2 NS (BID)
Drug: Mometasone Furoate-1 NS (QD)
Drug: Mometasone Furoate-2 NS (BID)
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301 placebo NS administered as 2 sprays/nostril
Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
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 \[i.e., causes interference with activities of daily living and/or sleeping\])
Time frame: 14 days
Subjects were enrolled at 10 sites in the US.
| Milestone | GSP 301 Placebo NS | GSP 301-1 NS (QD) | Mometasone Furoate-1 NS (QD) | Olopatadine HCl-1 NS (QD) | GSP 301-2 NS (BID) | Mometasone Furoate-2 NS (BID) | Olopatadine HCl-2 NS (BID) |
|---|---|---|---|---|---|---|---|
| Started | 159 | 158 | 160 | 158 | 157 | 159 | 160 |
| Completed | 155 | 155 | 157 | 155 | 152 | 153 | 158 |
| Not completed | 4 | 3 | 3 | 3 | 5 | 6 | 2 |
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 \[i.e., causes interference with activities of daily living and/or sleeping\])
| units on a scale | GSP 301 Placebo | GSP 301-1 NS (QD) | Mometasone Furoate-1 NS (QD) | Olopatadine HCl-1 NS (QD) | GSP 301-2 NS (BID) | Mometasone Furoate-2 NS (BID) | Olopatadine HCl-2 NS (BID) |
|---|---|---|---|---|---|---|---|
| Baseline | 10.3 ± 1.18 | 10.4 ± 1.24 | 10.4 ± 1.30 | 10.3 ± 1.26 | 10.4 ± 1.19 | 10.5 ± 1.13 | 10.3 ± 1.24 |
| Change from Baseline to Visit 4 | -1.4 ± 2.00 | -2.5 ± 2.52 | -2.2 ± 2.68 | -1.7 ± 2.09 | -2.6 ± 2.56 | -1.9 ± 1.88 | -2.1 ± 2.26 |
Collected over AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSP 301 Placebo NS | — | 0/159 (0%) | 0/159 (0%) |
| GSP 301-1 NS (QD) | — | 1/158 (0.6%) | 0/158 (0%) |
| Mometasone Furoate-1 NS (QD) | — | 0/160 (0%) | 0/160 (0%) |
| Olopatadine HCl-1 NS (QD) | — | 0/158 (0%) | 0/158 (0%) |
| GSP 301-2 NS (BID) | — | 0/157 (0%) | 0/157 (0%) |
| Mometasone Furoate-2 NS (BID) | — | 0/159 (0%) | 0/159 (0%) |
| Olopatadine HCl-2 NS (BID) | — | 0/160 (0%) | 0/160 (0%) |
| Event | GSP 301 Placebo NS | GSP 301-1 NS (QD) | Mometasone Furoate-1 NS (QD) | Olopatadine HCl-1 NS (QD) | GSP 301-2 NS (BID) | Mometasone Furoate-2 NS (BID) | Olopatadine HCl-2 NS (BID) |
|---|---|---|---|---|---|---|---|
| Gastrointestinal ulcer and GastritisGastrointestinal disorders | 0/159 | 1/158 | 0/160 | 0/158 | 0/157 | 0/159 | 0/160 |
| Age, Continuous(years) | GSP 301 Placebo NS | GSP 301-1 NS (QD) | Mometasone Furoate-1 NS (QD) | Olopatadine HCl-1 NS (QD) | GSP 301-2 NS (BID) | Mometasone Furoate-2 NS (BID) | Olopatadine HCl-2 NS (BID) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 45.35 ± 14.951 | 43.83 ± 13.609 | 44.40 ± 14.312 | 41.90 ± 12.478 | 43.44 ± 14.128 | 44.58 ± 13.698 | 43.49 ± 13.868 | 43.86 ± 13.882 |
| Sex: Female, Male(Participants) | GSP 301 Placebo NS | GSP 301-1 NS (QD) | Mometasone Furoate-1 NS (QD) | Olopatadine HCl-1 NS (QD) | GSP 301-2 NS (BID) | Mometasone Furoate-2 NS (BID) | Olopatadine HCl-2 NS (BID) | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 112 | 100 | 115 | 105 | 111 | 96 | 101 | 740 |
| Male | 47 | 58 | 45 | 53 | 46 | 63 | 59 | 371 |
The record gives a start of Dec 2014, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rhinitis, Allergic, Seasonal →
Glenmark Pharmaceuticals Ltd. India