7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: Placebo; Drug: TD-4208

• Registration Number: NCT01704404
• Lead Sponsor: Mylan Inc.

Brief Summary

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Study Start: 2012-12
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Results First Submitted: 2017-01-17
• Results First Submitted QC: 2017-01-20
• Results First Posted: 2017-03-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).

2. Subject:

   • Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) <0.7 at screening; and
   • Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.

3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.

4. Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.

5. Subject (or care giver) is able to properly prepare and administer study medication.

6. Subject is willing and able to give written informed consent to participate.

Exclusion Criteria

1. Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.
3. Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
5. Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value >450 msec (males) or >470 msec (females); or shows evidence of clinically significant rhythm abnormality.
6. Subject has a known hypersensitivity to TD-4208 or similar drug class.
7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Dose 1 TD-4208	TD-4208	22 µg
Dose 2 TD-4208	TD-4208	44 µg
Dose 3 TD-4208	TD-4208	88 µg
Dose 4 TD-4208	TD-4208	175 µg
Dose 5 TD-4208	TD-4208	350 µg
Dose 6 TD-4208	TD-4208	700 µg

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)	From baseline to day 7

Trial Locations

Locations (1)

P3 Research Ltd; 🇳🇿 Wellington, New Zealand