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A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

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Mylan

Status and phase

Completed
Phase 2

Conditions

COPD

Treatments

Drug: Placebo
Drug: TD-4208

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Enrollment

355 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is a male or female subject 40 years of age or older
  • Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
  • Subject is capable of performing reproducible spirometry maneuvers
  • Subject has post-bronchodilator FEV1/FVC ratio <0.7
  • Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
  • Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
  • Subject has a current or past smoking history of at least 10 pack-years.

Exclusion criteria

  • Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
  • Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
  • Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
  • Subject has been hospitalized for COPD or pneumonia within 12 weeks
  • Subject requires long-term oxygen therapy (>15 hours a day)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

355 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
44 mcg
Experimental group
Description:
TD-4208
Treatment:
Drug: TD-4208
88 mcg
Experimental group
Description:
TD-4208
Treatment:
Drug: TD-4208
175 mcg
Experimental group
Description:
TD-4208
Treatment:
Drug: TD-4208
350 mcg
Experimental group
Description:
TD-4208
Treatment:
Drug: TD-4208

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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