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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518139
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : December 31, 2018
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Mylan Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: TD-4208
Drug: Tiotropium
Enrollment 1060
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
Hide 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
Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium Total
Hide 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 Number of Baseline Participants 364 335 356 1055
Hide Baseline Analysis Population Description
1060 subjects were randomized. A total of 1055 subjects received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 335 participants 356 participants 1055 participants
<=18 years
0
   0.0%
0
   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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 364 participants 335 participants 356 participants 1055 participants
64.1  (9.36) 64.4  (8.61) 64.9  (8.91) 64.4  (8.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 335 participants 356 participants 1055 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 335 participants 356 participants 1055 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 335 participants 356 participants 1055 participants
American Indian or Alaska Native
0
   0.0%
0
   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
   0.0%
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
  93.0%
977
  92.6%
More than one race
1
   0.3%
2
   0.6%
0
   0.0%
3
   0.3%
Unknown or Not Reported
1
   0.3%
1
   0.3%
0
   0.0%
2
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 364 participants 335 participants 356 participants 1055 participants
364 335 356 1055
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 335 participants 356 participants 1055 participants
Current Smoker
171
  47.0%
151
  45.1%
167
  46.9%
489
  46.4%
Former Smoker
193
  53.0%
184
  54.9%
189
  53.1%
566
  53.6%
1.Primary Outcome
Title Adverse Events: Frequency and Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
Hide Arm/Group Description:

88 mcg

TD-4208

175 mcg

TD-4208

18 mcg

Tiotropium: Active comparator

Overall Number of Participants Analyzed 364 335 356
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Event (AE)
272
  74.7%
242
  72.2%
275
  77.2%
Moderate or Severe AE
226
  62.1%
174
  51.9%
210
  59.0%
Serious AE
58
  15.9%
43
  12.8%
58
  16.3%
Time Frame Adverse events were recorded from signing of the ICF through the final follow-up assessment (approximately 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TD-4208-1 TD-4208-2 Tiotropium
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/364 (0.27%)      1/335 (0.30%)      1/356 (0.28%)    
Hide 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 (15.93%)      43/335 (12.84%)      58/356 (16.29%)    
Blood and lymphatic system disorders       
Anaemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Haemorrhagic anaemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Cardiac disorders       
Acute myocardial infarction  1  1/364 (0.27%)  1 3/335 (0.90%)  3 2/356 (0.56%)  2
Myocardial infarction  1  4/364 (1.10%)  4 2/335 (0.60%)  2 0/356 (0.00%)  0
Atrial fibrillation  1  2/364 (0.55%)  2 0/335 (0.00%)  0 3/356 (0.84%)  3
Angina unstable  1  0/364 (0.00%)  0 2/335 (0.60%)  2 0/356 (0.00%)  0
Cardiac failure congestive  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Acute coronary syndrome  1  1/364 (0.27%)  1 0/335 (0.00%)  0 1/356 (0.28%)  1
Cardiac arrest  1  1/364 (0.27%)  1 0/335 (0.00%)  0 1/356 (0.28%)  1
Coronary artery occlusion  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Angina pectoris  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Atrial flutter  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Bradycardia  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Coronary artery disease  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Myocardial ischaemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Sinus node dysfunction  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Stress cardiomyopathy  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Tachycardia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Ear and labyrinth disorders       
Vertigo  1  0/364 (0.00%)  0 0/335 (0.00%)  0 2/356 (0.56%)  2
Endocrine disorders       
Goitre  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Gastrointestinal disorders       
Colitis  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Diverticulum intestinal haemorrhagic  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Pancreatitis acute  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Abdominal pain  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Ascites  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Duodenitis  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Dysphagia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Enteritis  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Gastritis  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Gastrointestinal angiodysplasia haemorrhagic  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Gastrointestinal haemorrhage  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Nausea  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Oesophagitis  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Pancreatic mass  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Rectal haemorrhage  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Small initestinal obstruction  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
General disorders       
Non-cardiac chest pain  1  3/364 (0.82%)  3 1/335 (0.30%)  1 0/356 (0.00%)  0
Chest pain  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Impaired healing  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Cardiac death  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Device malfunction  1  0/364 (0.00%)  0/335 (0.00%)  1/356 (0.28%) 
Systemic inflammatory response syndrome  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Hepatobiliary disorders       
Jaundice  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Infections and infestations       
Pneumonia  1  10/364 (2.75%)  10 1/335 (0.30%)  1 6/356 (1.69%)  6
Diverticulitis  1  1/364 (0.27%)  1 0/335 (0.00%)  0 2/356 (0.56%)  2
Cellulitis  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Appendicitis  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Bronchitis  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Pneumonia bacterial  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Abscess neck  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Appendicitis perforated  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Diverticulitis intestinal haemorrhagic  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Fungaemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Infected skin ulcer  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Ludwig angina  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Osteomyelitis  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Peritoneal abscess  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Post procedural infection  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Sepsis  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Staphylococcal bacteraemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Injury, poisoning and procedural complications       
Clavicle fracture  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Fall  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Hip fracture  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Laceration  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Lower limb fracture  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Multiple fractures  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Near drowning  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Procedural pain  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Rib fracture  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Road traffic accident  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Upper limb fracture  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Hyponatraemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  2/364 (0.55%)  2 2/335 (0.60%)  2 1/356 (0.28%)  1
Cervical spinal stenosis  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Arthralgia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Muscular weakness  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Musculoskeletal chest pain  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Spinal column stenosis  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm malignant  1  2/364 (0.55%)  2 0/335 (0.00%)  0 2/356 (0.56%)  2
Lung adenocarcinoma stage III  1  0/364 (0.00%)  0 0/335 (0.00%)  0 2/356 (0.56%)  2
Breast Cancer  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Lung adenocarcinoma  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Pancreatic carcinoma  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Small cell lung cancer  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Uterine leiomyoma  1  1/364 (0.27%)  1 0/335 (0.00%)  0 1/356 (0.28%)  1
Brain cancer metastatic  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Bronchial carcinoma  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Colon cancer  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Colon cancer stage 0  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Ear neoplasm  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Hepatic cancer  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Invasive ductal breast carcinoma  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Laryngeal cancer  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Laryngeal squamouse cell carcinoma  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Lung adenocarcinoma stage I  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Lung carcinoma cell type unspecified stage IV  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Oesophageal squamous cell carcinoma  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Ovarian cancer  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Prostate cancer  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Prostate cancer stage II  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Squamous cell carcinoma  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Ureteric cancer  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Nervous system disorders       
Carotid artery stenosis  1  0/364 (0.00%)  0 1/335 (0.30%)  1 1/356 (0.28%)  1
Depressed level of consciousness  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Hepatic encephalopathy  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Nerve compression  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Radiculopathy  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Syncope  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Psychiatric disorders       
Bipolar I disorder  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Delirium  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Mental status changes  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Renal and urinary disorders       
Hydronephrosis  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Renal artery stenosis  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Erectile dysfunction  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  13/364 (3.57%)  13 8/335 (2.39%)  8 13/356 (3.65%)  13
Acute respiratory failure  1  3/364 (0.82%)  3 3/335 (0.90%)  3 3/356 (0.84%)  3
Pneumothorax  1  0/364 (0.00%)  0 1/335 (0.30%)  1 2/356 (0.56%)  2
Pulmonary embolism  1  2/364 (0.55%)  2 0/335 (0.00%)  0 0/356 (0.00%)  0
Dyspnoea  1  1/364 (0.27%)  1 1/335 (0.30%)  1 0/356 (0.00%)  0
Hypoxia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Pleural effusion  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Pulmonary granuloma  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Pulmonary mass  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Respiratory failure  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Subcutaneous emphysema  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Vascular disorders       
Hypotension  1  1/364 (0.27%)  1 0/335 (0.00%)  0 1/356 (0.28%)  1
Accelerated hypertension  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Aortic aneurysm  1  1/364 (0.27%)  1 0/335 (0.00%)  0 0/356 (0.00%)  0
Circulatory collapse  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Hypertensive emergency  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
Peripheral arterial occlusive disease  1  0/364 (0.00%)  0 1/335 (0.30%)  1 0/356 (0.00%)  0
Peripheral ischaemia  1  0/364 (0.00%)  0 0/335 (0.00%)  0 1/356 (0.28%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
TD-4208-1 TD-4208-2 Tiotropium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   202/364 (55.49%)      166/335 (49.55%)      188/356 (52.81%)    
Gastrointestinal disorders       
Diarrhoea  1  14/364 (3.85%)  14 13/335 (3.88%)  13 9/356 (2.53%)  9
Nausea  1  7/364 (1.92%)  7 6/335 (1.79%)  6 12/356 (3.37%)  12
Gastrooesophageal reflux disease  1  8/364 (2.20%)  8 8/335 (2.39%)  8 8/356 (2.25%)  8
Infections and infestations       
Nasopharyngitis  1  28/364 (7.69%)  28 26/335 (7.76%)  26 17/356 (4.78%)  17
Upper Respiratory Tract Infection  1  24/364 (6.59%)  24 20/335 (5.97%)  20 24/356 (6.74%)  24
Urinary tract infection  1  20/364 (5.49%)  20 11/335 (3.28%)  11 15/356 (4.21%)  15
Bronchitis  1  17/364 (4.67%)  17 17/335 (5.07%)  17 9/356 (2.53%)  9
Sinusitis  1  15/364 (4.12%)  15 8/335 (2.39%)  8 9/356 (2.53%)  9
Musculoskeletal and connective tissue disorders       
Back Pain  1  10/364 (2.75%)  10 7/335 (2.09%)  7 10/356 (2.81%)  10
Anthralgia  1  9/364 (2.47%)  9 6/335 (1.79%)  6 11/356 (3.09%)  11
Nervous system disorders       
Headache  1  15/364 (4.12%)  15 13/335 (3.88%)  13 20/356 (5.62%)  20
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  107/364 (29.40%)  107 73/335 (21.79%)  73 100/356 (28.09%)  100
Cough  1  18/364 (4.95%)  18 25/335 (7.46%)  25 20/356 (5.62%)  20
Dyspnoea  1  31/364 (8.52%)  31 13/335 (3.88%)  13 13/356 (3.65%)  13
Pneumonia  1  16/364 (4.40%)  16 5/335 (1.49%)  5 14/356 (3.93%)  14
Vascular disorders       
Hypertension  1  18/364 (4.95%)  18 8/335 (2.39%)  8 16/356 (4.49%)  16
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Development & Medical Affairs
Organization: Theravance Biopharma
Phone: 1-855-633-8479
EMail: medinfo@theravance.com
Layout table for additonal information
Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02518139    
Other Study ID Numbers: 0128
First Submitted: August 5, 2015
First Posted: August 7, 2015
Results First Submitted: December 6, 2018
Results First Posted: December 31, 2018
Last Update Posted: May 7, 2021