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CompletedNCT03118765Updated Aug 1, 2019Results posted

Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 interventional study of GSP304 (tiotropium bromide) Inhalation Solution and GSP304 Placebo Inhalation Solution in Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD), sponsored by Glenmark Specialty S.A.. Completed at 25 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by Glenmark Specialty S.A. · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive — none open to participants now, none under way, none of them phase 3. tiotropium · Pulmonary Disease, Chronic Obstructive.

Enrollment
48th of 105
155 · median 131
Started
2017
with 8 others
Phase 2
10 of 105
none open now
Registered
90th of 105
by date

Among the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive, this one is the 48th largest by enrollment, is one of 9 that started in 2017, is one of 10 in phase 2, and was the 90th registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

None of the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive is open now. The open studies under Pulmonary Disease, Chronic Obstructive, anywhere →

About tiotropium

tiotropium: first FDA approval 2004 (SPIRIVA). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: 40 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 105 studies testing tiotropium in Pulmonary Disease, Chronic Obstructive as a file.
02

Study summary

Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).

03

Conditions studied

  • Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female subjects ≥40 years and ≤85 years of age at the time of consent.
  • Subject must have a primary diagnosis of mild or moderate defined as post-bronchodilator /FVC ratio of \<70% and FEV1 of ≥50% of predicted normal value as per the NHANES III predicted normal values at screening.
  • Willing to stop all other COPD medications or other medications which will interfere with the study results for the entire duration of the study, except albuterol/salbutamol as needed.
  • Current or ex-smoker with ≥10 pack-year smoking history.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a chest x-ray/CT scan that suggests a diagnosis other than (eg, pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. If there is no chest x-ray or CT scan taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed.
  • Use of oral/parenteral or antibiotics for COPD within 6 weeks or depot corticosteroids within 3 months prior to screening or subject has had a change in dose or type of any medications for COPD within 14 days before screening.
  • Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening.
  • Subjects with a history of asthma, with the exception of outgrown childhood asthma, defined as transient wheezers outgrown by 5 years of age.
  • Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
  • Subject requires nocturnal oxygen or continuous supplemental oxygen therapy.
  • Subject with history of a positive result for or antibody.
  • Subject is known to be seropositive for .
  • Female subject is pregnant or lactating.
  • Subject has a history of allergic reaction to the anti-cholinergic or any components of the study medications.
Terms in these criteria, in plain language(6)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    Test Treatment T1: GSP304 Inhalation Solution

    Drug: GSP304 (tiotropium bromide) Inhalation Solution

  • Experimental
    Test Treatment T2: GSP304 Inhalation Solution

    Drug: GSP304 (tiotropium bromide) Inhalation Solution

  • Experimental
    Test Treatment T3: GSP304 Inhalation Solution

    Drug: GSP304 (tiotropium bromide) Inhalation Solution

  • Placebo comparator
    Test Treatment T4: GSP304 Placebo Inhalation Solution

    Drug: GSP304 Placebo Inhalation Solution

  • Active comparator
    Test Treatment T5: Spiriva® Respimat® inhalation spray

    Drug: Spiriva® Respimat® inhalation spray

Interventions

  • DrugGSP304 (tiotropium bromide) Inhalation Solution

    Once daily (QD) oral inhalation using a nebulizer

  • DrugGSP304 Placebo Inhalation Solution

    Once daily (QD) oral inhalation using a nebulizer

  • DrugSpiriva® Respimat® inhalation spray

    Once daily (QD) oral inhalation

06

What researchers measure

Primary outcomes

  1. Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS

    The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)

    Time frame: Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.

  2. Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS

    The PK endpoint in plasma to assess the relative bioavailability was area under the plasma concentration-time curve of tiotropium over the dosing interval at steady state (AUC0-tauSS)

    Time frame: Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.

  3. Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.

    Change from baseline (Day 1) at Day 21 (Week 3) in trough FEV1 response at approximately 24 hours after the last dose (average of 23 hours 15 minutes and 23 hours 45 minutes postdose measurements), in comparison with placebo.

    Time frame: 21 days (Pre- dose trough FEV1 is mean FEV1 at -45 mins and -15 mins pre-morning dose at Day 1. Trough FEV1 is mean FEV1 obtained 23 hrs 15 mins and 23 hrs 45 mins post-morning dose of day 21).

Secondary outcomes

  1. Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1

    Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of tiotropium excreted in urine over the dosing interval on Day 1

    Time frame: Day 1

  2. Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

    Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

    Time frame: Day 21

  3. Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1

    Descriptive statistics for tiotropium urine PK parameter - Fraction of dose (Fe) of tiotropium excreted in urine over the dosing interval on Day 1

    Time frame: Day 1

  4. Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

    Descriptive statistics for tiotropium urine PK parameter-Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

    Time frame: Day 21

  5. Peak Concentrations During the Dosing Interval (Cmax) on Day 1

    Descriptive statistics for tiotropium plasma PK parameters - (Cmax) on Day 1

    Time frame: Day 1

  6. Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1

    Descriptive statistics for tiotropium plasma PK parameter - Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) on Day 1

    Time frame: Day 1

  7. Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1

    Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 1

    Time frame: Day 1

  8. Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21

    Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 21

    Time frame: Day 21

  9. Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 21

    Descriptive statistics for tiotropium plasma PK parameter - Average concentration during a dosing interval at steady state (CavSS) on day 21

    Time frame: Day 21

  10. Accumulation Ratio Rac(Auc)

    Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(auc). Rac(auc) was calculated as AUC0-tauSS/AUC0-tau.

    Time frame: Day 21

  11. Accumulation Ratio Rac(Cmax)

    Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(cmax). Rac(Cmax) was calculated as CmaxSS/Cmax.

    Time frame: Day 21

  12. Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1

    The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 1. Change from baseline in peak FEV1 within 12 hours postdose on Day 1 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.

    Time frame: Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).

  13. Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21

    The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 21. Change from baseline in peak FEV1 within 12 hours postdose on Day 21 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.

    Time frame: Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).

  14. Change From Baseline in Forced Vital Capacity (FVC) on Day 1

    Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 1.

    Time frame: Day 1 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 1. Postdose timing were relative to the end of dosing.The window for 1 hour spirometry and thereafter was ±5 minutes).

  15. Change From Baseline in Forced Vital Capacity (FVC) on Day 21

    Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 21

    Time frame: Day 21 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 21. Postdose timing were relative to the end of dosing. The window for 1 hour spirometry and thereafter was ±5 minutes).

  16. Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1

    Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 measured over 12 hours on Day 1.

    Time frame: Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).

  17. Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21

    Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 Measured Over 12 Hours on Day 21.

    Time frame: Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).

07

Results

Posted Aug 1, 2019

Participant flow

Participant flow — Overall Study
MilestoneGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Started3032313230
Completed2630262928
Not completed42532
Withdrew: Withdrawal by subject00100
Withdrew: Adverse event11111
Withdrew: Non compliance with study procedures00010
Withdrew: Violation of inclusion/exclusioncriteria01100
Withdrew: Copd exacerbation10010
Withdrew: Lost to follow-up10100
Withdrew: Sponsor decision10101

Outcome measures

PrimaryRelative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS

The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)

Time frame:
Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.
Reported as:
Mean · pg/mL
Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS
pg/mLGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS4.10 ± 1.1528.00 ± 1.14021.80 ± 1.15214.00 ± 1.152
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 29.4 · 90% CI 21.14 to 41.00Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 57 · 90% CI 41.37 to 78.46Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 155.80 · 90% CI 111.88 to 216.99Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT
PrimaryRelative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS

The PK endpoint in plasma to assess the relative bioavailability was area under the plasma concentration-time curve of tiotropium over the dosing interval at steady state (AUC0-tauSS)

Time frame:
Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.
Reported as:
Mean · h*pg/mL
Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS
h*pg/mLGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS22.90 ± 1.13049.10 ± 1.123122.00 ± 1.13057.70 ± 1.130
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 39.70 · 90% CI 29.79 to 52.87Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 85.20 · 90% CI 64.43 to 112.64Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg · Ls mean ratio (%): 211.50 · 90% CI 158.80 to 281.80Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT
PrimaryChange From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.

Change from baseline (Day 1) at Day 21 (Week 3) in trough FEV1 response at approximately 24 hours after the last dose (average of 23 hours 15 minutes and 23 hours 45 minutes postdose measurements), in comparison with placebo.

Time frame:
21 days (Pre- dose trough FEV1 is mean FEV1 at -45 mins and -15 mins pre-morning dose at Day 1. Trough FEV1 is mean FEV1 obtained 23 hrs 15 mins and 23 hrs 45 mins post-morning dose of day 21).
Reported as:
Mean · L
Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.
LGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.0.14 ± 0.040.10 ± 0.040.09 ± 0.040.08 ± 0.040.14 ± 0.04
Statistical analysis
  • GSP304 10 μg vs Placebo · MMRM · p = 0.228 · Mean difference (final values): 0.06 · 95% CI -0.04 to 0.17
  • GSP304 20 μg vs Placebo · MMRM · p = 0.655 · Mean difference (net): 0.02 · 95% CI -0.08 to 0.13
  • GSP304 40 μg vs Placebo · MMRM · p = 0.894 · Mean difference (final values): 0.01 · 95% CI -0.10 to 0.11
  • Placebo vs SPIRIVA RESPIMAT 5 μg · MMRM · p = 0.260 · Mean difference (final values): 0.06 · 95% CI -0.04 to 0.16
SecondaryAmount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1

Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of tiotropium excreted in urine over the dosing interval on Day 1

Time frame:
Day 1
Reported as:
Mean · pg
Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
pgGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1138600 ± 76830336100 ± 233800602900 ± 422400247400 ± 219600
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryAmount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

Time frame:
Day 21
Reported as:
Mean · pg
Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
pgGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21375400 ± 286900647100 ± 4600001611000 ± 1013000775500 ± 458000
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryFraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1

Descriptive statistics for tiotropium urine PK parameter - Fraction of dose (Fe) of tiotropium excreted in urine over the dosing interval on Day 1

Time frame:
Day 1
Reported as:
Mean · percentage of dose
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
percentage of doseGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 11.386 ± 0.76831.681 ± 1.1691.507 ± 1.0564.948 ± 4.391
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryFraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

Descriptive statistics for tiotropium urine PK parameter-Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21

Time frame:
Day 21
Reported as:
Mean · percentage of dose
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
percentage of doseGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 213.754 ± 2.8693.236 ± 2.3004.026 ± 2.53215.51 ± 9.161
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryPeak Concentrations During the Dosing Interval (Cmax) on Day 1

Descriptive statistics for tiotropium plasma PK parameters - (Cmax) on Day 1

Time frame:
Day 1
Reported as:
Mean · pg/mL
Peak Concentrations During the Dosing Interval (Cmax) on Day 1
pg/mLGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Peak Concentrations During the Dosing Interval (Cmax) on Day 12.632 ± 1.6907.119 ± 7.36814.06 ± 11.9810.25 ± 7.944
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryArea Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1

Descriptive statistics for tiotropium plasma PK parameter - Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) on Day 1

Time frame:
Day 1
Reported as:
Mean · pg*h/mL
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1
pg*h/mLGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 110.65 ± 7.04922.94 ± 13.0952.11 ± 34.722.64 ± 10.69
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryTime of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1

Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 1

Time frame:
Day 1
Reported as:
Median · hour
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1
hourGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 10.067 (0.03 to 0.18)0.100 (0.03 to 8.02)0.108 (0.03 to 0.75)0.100 (0.03 to 3.98)
SecondaryTime of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21

Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 21

Time frame:
Day 21
Reported as:
Median · hour
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21
hourGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 210.075 (0.03 to 0.25)0.150 (0.04 to 16.00)0.108 (0.05 to 1.00)0.100 (0.03 to 0.75)
SecondaryAverage Concentration During a Dosing Interval at Steady State (CavSS) on Day 21

Descriptive statistics for tiotropium plasma PK parameter - Average concentration during a dosing interval at steady state (CavSS) on day 21

Time frame:
Day 21
Reported as:
Mean · pg/mL
Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 21
pg/mLGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 211.120 ± 0.83012.436 ± 1.6236.273 ± 4.0522.725 ± 1.289
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryAccumulation Ratio Rac(Auc)

Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(auc). Rac(auc) was calculated as AUC0-tauSS/AUC0-tau.

Time frame:
Day 21
Reported as:
Mean · ratio
Accumulation Ratio Rac(Auc)
ratioGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Accumulation Ratio Rac(Auc)2.966 ± 1.5615.328 ± 13.533.667 ± 2.8733.699 ± 2.897
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryAccumulation Ratio Rac(Cmax)

Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(cmax). Rac(Cmax) was calculated as CmaxSS/Cmax.

Time frame:
Day 21
Reported as:
Mean · ratio
Accumulation Ratio Rac(Cmax)
ratioGSP304 10 μgGSP304 20 μgGSP304 40 μgSPIRIVA RESPIMAT 5 μg
Accumulation Ratio Rac(Cmax)2.063 ± 0.71873.492 ± 7.4362.622 ± 2.0592.835 ± 2.612
Statistical analysis
  • GSP304 10 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 20 μg vs SPIRIVA RESPIMAT 5 μg ·
  • GSP304 40 μg vs SPIRIVA RESPIMAT 5 μg ·
SecondaryChange From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1

The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 1. Change from baseline in peak FEV1 within 12 hours postdose on Day 1 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.

Time frame:
Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Reported as:
Least squares mean · Litre
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 10.34 ± 0.030.38 ± 0.030.33 ± 0.040.21 ± 0.030.38 ± 0.03
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.004 · Mean difference (final values): 0.13 · 95% CI 0.04 to 0.21
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 0.17 · 95% CI 0.08 to 0.26
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.007 · Mean difference (final values): 0.12 · 95% CI 0.03 to 0.21
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 0.17 · 95% CI 0.08 to 0.26
SecondaryChange From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21

The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 21. Change from baseline in peak FEV1 within 12 hours postdose on Day 21 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.

Time frame:
Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Reported as:
Least squares mean · Litre
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 210.37 ± 0.040.34 ± 0.040.31 ± 0.040.20 ± 0.040.37 ± 0.04
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.001 · Mean difference (final values): 0.18 · 95% CI 0.08 to 0.28
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = 0.005 · Mean difference (final values): 0.15 · 95% CI 0.05 to 0.25
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.032 · Mean difference (final values): 0.11 · 95% CI 0.01 to 0.21
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = 0.001 · Mean difference (final values): 0.17 · 95% CI 0.07 to 0.27
SecondaryChange From Baseline in Forced Vital Capacity (FVC) on Day 1

Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 1.

Time frame:
Day 1 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 1. Postdose timing were relative to the end of dosing.The window for 1 hour spirometry and thereafter was ±5 minutes).
Reported as:
Least squares mean · Litre
Change From Baseline in Forced Vital Capacity (FVC) on Day 1
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Forced Vital Capacity (FVC) on Day 10.21 ± 0.050.21 ± 0.050.18 ± 0.050.13 ± 0.050.16 ± 0.05
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.166 · Mean difference (final values): 0.09 · 95% CI -0.04 to 0.21
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = 0.182 · Mean difference (final values): 0.08 · 95% CI -0.04 to 0.21
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.401 · Mean difference (final values): 0.05 · 95% CI -0.07 to 0.17
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = 0.574 · Mean difference (final values): 0.03 · 95% CI -0.09 to 0.16
SecondaryChange From Baseline in Forced Vital Capacity (FVC) on Day 21

Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 21

Time frame:
Day 21 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 21. Postdose timing were relative to the end of dosing. The window for 1 hour spirometry and thereafter was ±5 minutes).
Reported as:
Least squares mean · Litre
Change From Baseline in Forced Vital Capacity (FVC) on Day 21
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Forced Vital Capacity (FVC) on Day 210.16 ± 0.060.10 ± 0.060.11 ± 0.060.11 ± 0.060.16 ± 0.06
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.493 · Mean difference (final values): 0.05 · 95% CI -0.10 to 0.21
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = 0.864 · Mean difference (final values): -0.01 · 95% CI -0.17 to 0.14
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.978 · Mean difference (final values): -0.00 · 95% CI -0.16 to 0.15
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = 0.500 · Mean difference (final values): 0.05 · 95% CI -0.10 to 0.20
SecondaryChange From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1

Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 measured over 12 hours on Day 1.

Time frame:
Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Reported as:
Least squares mean · Litre
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 10.22 ± 0.030.24 ± 0.030.24 ± 0.030.10 ± 0.030.26 ± 0.03
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.003 · Mean difference (final values): 0.12 · 95% CI 0.04 to 0.20
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = 0.001 · Mean difference (final values): 0.14 · 95% CI 0.06 to 0.22
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.001 · Mean difference (final values): 0.13 · 95% CI 0.06 to 0.21
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = <0.001 · Mean difference (final values): 0.16 · 95% CI 0.08 to 0.23
SecondaryChange From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21

Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 Measured Over 12 Hours on Day 21.

Time frame:
Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Reported as:
Least squares mean · Litre
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21
LitreGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 210.23 ± 0.040.17 ± 0.030.15 ± 0.040.08 ± 0.040.23 ± 0.03
Statistical analysis
  • GSP304 10 μg vs Placebo · Mixed Models Analysis · p = 0.002 · Mean difference (final values): 0.15 · 95% CI 0.06 to 0.24
  • GSP304 20 μg vs Placebo · Mixed Models Analysis · p = 0.061 · Mean difference (final values): 0.09 · 95% CI -0.00 to 0.18
  • GSP304 40 μg vs Placebo · Mixed Models Analysis · p = 0.140 · Mean difference (final values): 0.07 · 95% CI -0.02 to 0.16
  • Placebo vs SPIRIVA RESPIMAT 5 μg · Mixed Models Analysis · p = 0.002 · Mean difference (final values): 0.15 · 95% CI 0.06 to 0.24

Adverse events

Collected over The AEs and SAEs were collected from the time of signing the informed consent form until the end of study and the follow-up contact which was approximately 9 weeks i.e., upto 2 weeks of screening, 2 weeks of run-in period, 3 weeks of treatment and follow up of 2 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSP304 10 μg0/30 (0%)0/30 (0%)3/30 (10%)
GSP304 20 μg0/32 (0%)0/32 (0%)6/32 (18.8%)
GSP304 40 μg0/31 (0%)0/31 (0%)5/31 (16.1%)
Placebo0/33 (0%)0/33 (0%)4/33 (12.1%)
SPIRIVA RESPIMAT 5 μg0/30 (0%)0/30 (0%)6/30 (20%)
Most frequent other events
Most frequent other events
EventGSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μg
Dry mouthGastrointestinal disorders0/301/324/310/330/30
CoughRespiratory, thoracic and mediastinal disorders1/301/320/310/333/30
HeadacheNervous system disorders1/302/320/311/333/30
Urinary tract infectionInfections and infestations1/300/320/311/332/30
Back painMusculoskeletal and connective tissue disorders0/302/320/311/330/30
DizzinessNervous system disorders0/300/321/312/331/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)GSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μgTotal
Mean63.2 ± 7.1261.6 ± 10.3465.4 ± 10.0265.0 ± 9.5162.0 ± 9.4263.4 ± 9.38
Sex: Female, Male
Sex: Female, Male(Participants)GSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μgTotal
Female131114172075
Male172117151080
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μgTotal
Hispanic or Latino2341212
Not Hispanic or Latino2829273128143
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μgTotal
American Indian or Alaska Native000000
Asian100001
Native Hawaiian or Other Pacific Islander000000
Black or African American2721113
White2725293129141
More than one race000000
Unknown or Not Reported000000
BMI
BMI(kg/m^2)GSP304 10 μgGSP304 20 μgGSP304 40 μgPlaceboSPIRIVA RESPIMAT 5 μgTotal
Mean25.848 ± 2.893626.150 ± 4.000724.799 ± 3.713825.409 ± 3.532125.503 ± 3.180925.543 ± 3.4803
08

Study locations

25 sites
  • Glenmark Investigational Site 23
    Andalusia, Alabama 36420, United States
  • Glenmark Investigational Site 12
    Phoenix, Arizona 85006, United States
  • Glenmark Investigational Site 14
    Tempe, Arizona 85283, United States
  • Glenmark Investigational Site 17
    Fullerton, California 92835, United States
  • Glenmark Investigational Site 19
    Edgewater, Florida 32132, United States
  • Glenmark Investigational Site 10
    Miami Lakes, Florida 33016, United States
  • Glenmark Investigational Site 24
    Miami, Florida 33144, United States
  • Glenmark Investigational Site 16
    Miami, Florida 33186, United States
  • Glenmark Investigational Site 6
    Orlando, Florida 32825, United States
  • Glenmark Investigational Site 20
    Ormond Beach, Florida 32124, United States
  • Glenmark Investigational Site 21
    Vero Beach, Florida 32960, United States
  • Glenmark Investigational Site 13
    Winter Park, Florida 32789, United States
  • Glenmark Investigational Site 18
    Las Vegas, Nevada 89119, United States
  • Glenmark Investigational Site 9
    Charlotte, North Carolina 28207, United States
  • Glenmark Investigational Site 5
    Columbus, Ohio 43213, United States
  • Glenmark Investigational Site 22
    Columbus, Ohio 43215, United States
  • Glenmark Investigational Site 8
    Dublin, Ohio 43016, United States
  • Glenmark Investigational Site 11
    Medford, Oregon 97504-9741, United States
  • Glenmark Investigational Site 3
    Easley, South Carolina 29640, United States
  • Glenmark Investigational Site 2
    Greenville, South Carolina 29615, United States
  • Glenmark Investigational Site 4
    Greenville, South Carolina 29615, United States
  • Glenmark Investigational Site 1
    Rock Hill, South Carolina 29732, United States
  • Glenmark Investigational Site 15
    Spartanburg, South Carolina 29303, United States
  • Glenmark Investigational Site 7
    Spartanburg, South Carolina 29303, United States
  • Glenmark Investigational Site 25
    Tomball, Texas 77375, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Jul 2017, 4 months.

Results were first posted in Aug 2019, 2 years after primary completion. A results delay was requested in Jul 2018.

Of 118 industry-sponsored phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 4 months is below that.

Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
Apr 18, 2017
StartActual
Mar 24, 2017
Primary completionActual
Jul 31, 2017
CompletionActual
Jul 31, 2017
Results delay requested
Jul 18, 2018
Results first posted
Aug 1, 2019
Last update
Aug 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03118765
Lead sponsor
Glenmark Specialty S.A.
Responsible party
Sponsor
First posted
Apr 18, 2017
Start date
Mar 24, 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Results posted
Aug 1, 2019
Last update
Aug 1, 2019

Study contacts

Cynthia Caracta, MD FCCP
study director · Glenmark Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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