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A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Sponsor
Mylan Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02518139
Collaborator
Theravance Biopharma (Industry)
1,060
Enrollment
1
Location
3
Arms
21
Actual Duration (Months)
50.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1060 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: TD-4208-1

88 mcg

Drug: TD-4208
Subjects receiving TD-4208 are blinded to one of two doses of 4208.
Other Names:
  • revefenacin

    		•
    Experimental: TD-4208-2

    175 mcg

    Drug: TD-4208
    Subjects receiving TD-4208 are blinded to one of two doses of 4208.
    Other Names:
  • revefenacin

    		•
    Active Comparator: Tiotropium

    18 mcg

    Drug: Tiotropium
    There is not a placebo, there is an active comparator (Tiotropium) arm.

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events: Frequency and Severity [Baseline to Day 365]

      To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject is a male or female subject 40 years of age or older
    Exclusion Criteria:
    • Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palmetto Medical Research Associates L.L.C Easley South Carolina United States 29640

    Sponsors and Collaborators

    • Mylan Inc.
    • Theravance Biopharma

    Investigators

    • Study Director: Medical Monitor, Theravance Biopharma

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mylan Inc.
    ClinicalTrials.gov Identifier:
    NCT02518139
    Other Study ID Numbers:
    • 0128
    First Posted:
    Aug 7, 2015
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Mylan Inc.
    Chronic Obstructive Pulmonary Disease, COPD
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Tiotropium Bromide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
    Arm/Group Description 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 18 mcg Tiotropium: Active comparator
    Period Title: Overall Study
    STARTED 364 335 356
    COMPLETED 219 191 262
    NOT COMPLETED 145 144 94

    Baseline Characteristics

    Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium Total
    Arm/Group Description 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 18 mcg Tiotropium: Active comparator Total of all reporting groups
    Overall Participants 364 335 356 1055
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    183
    50.3%
    167
    49.9%
    163
    45.8%
    513
    48.6%
    >=65 years
    181
    49.7%
    168
    50.1%
    193
    54.2%
    542
    51.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.1
    (9.36)
    64.4
    (8.61)
    64.9
    (8.91)
    64.4
    (8.97)
    Sex: Female, Male (Count of Participants)
    Female
    158
    43.4%
    139
    41.5%
    142
    39.9%
    439
    41.6%
    Male
    206
    56.6%
    196
    58.5%
    214
    60.1%
    616
    58.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    6
    1.6%
    5
    1.5%
    3
    0.8%
    14
    1.3%
    Not Hispanic or Latino
    357
    98.1%
    326
    97.3%
    352
    98.9%
    1035
    98.1%
    Unknown or Not Reported
    1
    0.3%
    4
    1.2%
    1
    0.3%
    6
    0.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    0.3%
    2
    0.6%
    1
    0.3%
    4
    0.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    24
    6.6%
    21
    6.3%
    24
    6.7%
    69
    6.5%
    White
    337
    92.6%
    309
    92.2%
    331
    93%
    977
    92.6%
    More than one race
    1
    0.3%
    2
    0.6%
    0
    0%
    3
    0.3%
    Unknown or Not Reported
    1
    0.3%
    1
    0.3%
    0
    0%
    2
    0.2%
    Region of Enrollment (participants) [Number]
    United States
    364
    100%
    335
    100%
    356
    100%
    1055
    100%
    Smoking Status (Count of Participants)
    Current Smoker
    171
    47%
    151
    45.1%
    167
    46.9%
    489
    46.4%
    Former Smoker
    193
    53%
    184
    54.9%
    189
    53.1%
    566
    53.6%

    Outcome Measures

    1. Primary Outcome
    Title Adverse Events: Frequency and Severity
    Description To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)
    Time Frame Baseline to Day 365

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
    Arm/Group Description 88 mcg TD-4208 175 mcg TD-4208 18 mcg Tiotropium: Active comparator
    Measure Participants 364 335 356
    Adverse Event (AE)
    272
    74.7%
    242
    72.2%
    275
    77.2%
    Moderate or Severe AE
    226
    62.1%
    174
    51.9%
    210
    59%
    Serious AE
    58
    15.9%
    43
    12.8%
    58
    16.3%

    Adverse Events

    Time Frame Adverse events were recorded from signing of the ICF through the final follow-up assessment (approximately 1 year)
    Adverse Event Reporting Description
    Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
    Arm/Group Description 88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium. 18 mcg Tiotropium: Active comparator
    All Cause Mortality
    TD-4208-1 TD-4208-2 Tiotropium
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/364 (0.3%) 1/335 (0.3%) 1/356 (0.3%)
    Serious Adverse Events
    TD-4208-1 TD-4208-2 Tiotropium
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 58/364 (15.9%) 43/335 (12.8%) 58/356 (16.3%)
    Blood and lymphatic system disorders
    Anaemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Haemorrhagic anaemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Cardiac disorders
    Acute myocardial infarction 1/364 (0.3%) 1 3/335 (0.9%) 3 2/356 (0.6%) 2
    Myocardial infarction 4/364 (1.1%) 4 2/335 (0.6%) 2 0/356 (0%) 0
    Atrial fibrillation 2/364 (0.5%) 2 0/335 (0%) 0 3/356 (0.8%) 3
    Angina unstable 0/364 (0%) 0 2/335 (0.6%) 2 0/356 (0%) 0
    Cardiac failure congestive 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Acute coronary syndrome 1/364 (0.3%) 1 0/335 (0%) 0 1/356 (0.3%) 1
    Cardiac arrest 1/364 (0.3%) 1 0/335 (0%) 0 1/356 (0.3%) 1
    Coronary artery occlusion 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Angina pectoris 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Atrial flutter 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Bradycardia 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Coronary artery disease 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Myocardial ischaemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Sinus node dysfunction 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Stress cardiomyopathy 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Tachycardia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Ear and labyrinth disorders
    Vertigo 0/364 (0%) 0 0/335 (0%) 0 2/356 (0.6%) 2
    Endocrine disorders
    Goitre 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Gastrointestinal disorders
    Colitis 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Diverticulum intestinal haemorrhagic 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Pancreatitis acute 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Abdominal pain 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Ascites 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Duodenitis 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Dysphagia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Enteritis 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Gastritis 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Gastrointestinal angiodysplasia haemorrhagic 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Gastrointestinal haemorrhage 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Nausea 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Oesophagitis 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Pancreatic mass 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Rectal haemorrhage 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Upper gastrointestinal haemorrhage 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Small initestinal obstruction 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    General disorders
    Non-cardiac chest pain 3/364 (0.8%) 3 1/335 (0.3%) 1 0/356 (0%) 0
    Chest pain 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Impaired healing 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Cardiac death 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Device malfunction 0/364 (0%) 0/335 (0%) 1/356 (0.3%)
    Systemic inflammatory response syndrome 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Hepatobiliary disorders
    Jaundice 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Infections and infestations
    Pneumonia 10/364 (2.7%) 10 1/335 (0.3%) 1 6/356 (1.7%) 6
    Diverticulitis 1/364 (0.3%) 1 0/335 (0%) 0 2/356 (0.6%) 2
    Cellulitis 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Appendicitis 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Bronchitis 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Pneumonia bacterial 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Abscess neck 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Appendicitis perforated 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Diverticulitis intestinal haemorrhagic 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Fungaemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Infected skin ulcer 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Ludwig angina 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Osteomyelitis 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Peritoneal abscess 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Post procedural infection 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Sepsis 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Staphylococcal bacteraemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Injury, poisoning and procedural complications
    Clavicle fracture 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Fall 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Hip fracture 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Laceration 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Lower limb fracture 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Multiple fractures 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Near drowning 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Procedural pain 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Rib fracture 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Road traffic accident 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Upper limb fracture 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Hyponatraemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 2/364 (0.5%) 2 2/335 (0.6%) 2 1/356 (0.3%) 1
    Cervical spinal stenosis 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Arthralgia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Muscular weakness 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Musculoskeletal chest pain 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Spinal column stenosis 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant 2/364 (0.5%) 2 0/335 (0%) 0 2/356 (0.6%) 2
    Lung adenocarcinoma stage III 0/364 (0%) 0 0/335 (0%) 0 2/356 (0.6%) 2
    Breast Cancer 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Lung adenocarcinoma 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Pancreatic carcinoma 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Small cell lung cancer 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Uterine leiomyoma 1/364 (0.3%) 1 0/335 (0%) 0 1/356 (0.3%) 1
    Brain cancer metastatic 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Bronchial carcinoma 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Colon cancer 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Colon cancer stage 0 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Ear neoplasm 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Hepatic cancer 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Invasive ductal breast carcinoma 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Laryngeal cancer 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Laryngeal squamouse cell carcinoma 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Lung adenocarcinoma stage I 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Lung carcinoma cell type unspecified stage IV 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Oesophageal squamous cell carcinoma 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Ovarian cancer 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Prostate cancer 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Prostate cancer stage II 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Squamous cell carcinoma 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Ureteric cancer 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Nervous system disorders
    Carotid artery stenosis 0/364 (0%) 0 1/335 (0.3%) 1 1/356 (0.3%) 1
    Depressed level of consciousness 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Hepatic encephalopathy 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Nerve compression 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Radiculopathy 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Syncope 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Psychiatric disorders
    Bipolar I disorder 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Delirium 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Mental status changes 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Renal and urinary disorders
    Hydronephrosis 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Renal artery stenosis 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Erectile dysfunction 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 13/364 (3.6%) 13 8/335 (2.4%) 8 13/356 (3.7%) 13
    Acute respiratory failure 3/364 (0.8%) 3 3/335 (0.9%) 3 3/356 (0.8%) 3
    Pneumothorax 0/364 (0%) 0 1/335 (0.3%) 1 2/356 (0.6%) 2
    Pulmonary embolism 2/364 (0.5%) 2 0/335 (0%) 0 0/356 (0%) 0
    Dyspnoea 1/364 (0.3%) 1 1/335 (0.3%) 1 0/356 (0%) 0
    Hypoxia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Pleural effusion 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Pulmonary granuloma 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Pulmonary mass 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Respiratory failure 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Subcutaneous emphysema 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Vascular disorders
    Hypotension 1/364 (0.3%) 1 0/335 (0%) 0 1/356 (0.3%) 1
    Accelerated hypertension 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Aortic aneurysm 1/364 (0.3%) 1 0/335 (0%) 0 0/356 (0%) 0
    Circulatory collapse 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Hypertensive emergency 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Peripheral arterial occlusive disease 0/364 (0%) 0 1/335 (0.3%) 1 0/356 (0%) 0
    Peripheral ischaemia 0/364 (0%) 0 0/335 (0%) 0 1/356 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    TD-4208-1 TD-4208-2 Tiotropium
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 202/364 (55.5%) 166/335 (49.6%) 188/356 (52.8%)
    Gastrointestinal disorders
    Diarrhoea 14/364 (3.8%) 14 13/335 (3.9%) 13 9/356 (2.5%) 9
    Nausea 7/364 (1.9%) 7 6/335 (1.8%) 6 12/356 (3.4%) 12
    Gastrooesophageal reflux disease 8/364 (2.2%) 8 8/335 (2.4%) 8 8/356 (2.2%) 8
    Infections and infestations
    Nasopharyngitis 28/364 (7.7%) 28 26/335 (7.8%) 26 17/356 (4.8%) 17
    Upper Respiratory Tract Infection 24/364 (6.6%) 24 20/335 (6%) 20 24/356 (6.7%) 24
    Urinary tract infection 20/364 (5.5%) 20 11/335 (3.3%) 11 15/356 (4.2%) 15
    Bronchitis 17/364 (4.7%) 17 17/335 (5.1%) 17 9/356 (2.5%) 9
    Sinusitis 15/364 (4.1%) 15 8/335 (2.4%) 8 9/356 (2.5%) 9
    Musculoskeletal and connective tissue disorders
    Back Pain 10/364 (2.7%) 10 7/335 (2.1%) 7 10/356 (2.8%) 10
    Anthralgia 9/364 (2.5%) 9 6/335 (1.8%) 6 11/356 (3.1%) 11
    Nervous system disorders
    Headache 15/364 (4.1%) 15 13/335 (3.9%) 13 20/356 (5.6%) 20
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease 107/364 (29.4%) 107 73/335 (21.8%) 73 100/356 (28.1%) 100
    Cough 18/364 (4.9%) 18 25/335 (7.5%) 25 20/356 (5.6%) 20
    Dyspnoea 31/364 (8.5%) 31 13/335 (3.9%) 13 13/356 (3.7%) 13
    Pneumonia 16/364 (4.4%) 16 5/335 (1.5%) 5 14/356 (3.9%) 14
    Vascular disorders
    Hypertension 18/364 (4.9%) 18 8/335 (2.4%) 8 16/356 (4.5%) 16

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Head of Clinical Development & Medical Affairs
    Organization Theravance Biopharma
    Phone 1-855-633-8479
    Email medinfo@theravance.com
    Responsible Party:
    Mylan Inc.
    ClinicalTrials.gov Identifier:
    NCT02518139
    Other Study ID Numbers:
    • 0128
    First Posted:
    Aug 7, 2015
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022