CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
GSP304 (tiotropium bromide) Inhalation Solution +2 moredrug
Likely dose
GSP304 tiotropium bromide inhalation solution — three doses tested, once daily by nebulizer; Spiriva® Respimat® once daily for comparisonAI-extracted
Key inclusion· 4
  • ✓Age 40–85 years at consent
  • ✓Primary diagnosis of mild or moderate COPD with post-bronchodilator FEV1/FVC ratio <70% and FEV1 ≥50% predicted (NHANES III)
  • ✓Current or ex-smoker with ≥10 pack-year smoking history
  • ✓Willing to discontinue other COPD medications and interfering medications for study duration, except albuterol/salbutamol as needed
Key exclusion· 11
  • ✕Chest x-ray/CT within 6 months suggesting diagnosis other than COPD (pneumonia, infection, atelectasis, pneumothorax, or other active/ongoing pulmonary condition)
  • ✕Oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks, or depot corticosteroids within 3 months, prior to screening
  • ✕Change in dose or type of any COPD medications within 14 days before screening
  • ✕Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03118765
NCT03118765Phase 2Completed
CompareCT.gov

A Dose Ranging, Parallel Group, Active (Spiriva® Respimat®) And Placebo Controlled Study To Assess Relative Bioavailability, Pharmacodynamics And Safety Of Three Doses Of Tiotropium Bromide Inhalation Solution In Subjects With Mild To Moderate Chronic Obstructive Pulmonary Disease

Glenmark Specialty S.A.·interventional·Posted Apr 18, 2017·Updated Aug 1, 2019

In Brief

A Phase 2 clinical trial evaluating GSP304 (tiotropium bromide) Inhalation Solution, GSP304 Placebo Inhalation Solution, and 1 other intervention for Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 155 participants across 25 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartMar 24, 2017
Primary CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.2 years ago

Interventions

GSP304 (tiotropium bromide) Inhalation Solutiondrug

Once daily (QD) oral inhalation using a nebulizer

GSP304 Placebo Inhalation Solutiondrug

Once daily (QD) oral inhalation using a nebulizer

Spiriva® Respimat® inhalation spraydrug

Once daily (QD) oral inhalation