A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Mylan

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Drug: Placebo; Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02109172

0116

Details and patient eligibility

About

This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.

Enrollment: 64 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7
• Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
• Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
• Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
• 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 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: Crossover Assignment

Masking: Triple Blind

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64 participants in 3 patient groups, including a placebo group

TD-4208 44 mcg twice daily

Experimental group

Description:

TD-4208 inhalation solution 44 mcg twice daily for 7 days

Treatment:

Drug: TD-4208

Placebo

Placebo Comparator group

Description:

Placebo inhalation solution twice daily for 7 days

Treatment:

Drug: Placebo

TD-4208 175 mcg once daily

Experimental group

Description:

TD-4208 inhalation solution 175 mcg once daily, placebo once daily

Treatment:

Drug: TD-4208

Drug: Placebo