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Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)

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ClinicalTrials.gov Identifier: NCT01608490
Recruitment Status : Terminated (FDA approval of supplementation to IDE to terminate subject long term follow up)
First Posted : May 31, 2012
Results First Posted : June 27, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Emphysema
Intervention Device: RePneu Lung Volume Reduction Coil System
Enrollment 315
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Hide Arm/Group Description

The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Period Title: Overall Study
Started 158 157
Completed 158 157
Not Completed 0 0
Arm/Group Title RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care Total
Hide Arm/Group Description

The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group. Total of all reporting groups
Overall Number of Baseline Participants 158 157 315
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants 157 participants 315 participants
63.4  (8.05) 64.3  (7.76) 63.9  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 315 participants
Female
86
  54.4%
79
  50.3%
165
  52.4%
Male
72
  45.6%
78
  49.7%
150
  47.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 157 participants 315 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
157
  99.4%
157
 100.0%
314
  99.7%
Unknown or Not Reported
1
   0.6%
0
   0.0%
1
   0.3%
1.Primary Outcome
Title Meters: 6 Minute Walk Test
Hide Description mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups
Time Frame baseline through 12 months follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were analyzed at 12 months.
Arm/Group Title RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Hide Arm/Group Description:

The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Overall Number of Participants Analyzed 158 157
Mean (Standard Error)
Unit of Measure: meters
0.8  (5.89) -8.6  (5.17)
2.Secondary Outcome
Title Mean Percent Change in FEV1
Hide Description Mean percent change in FEV1 at 12 months
Time Frame BL to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Hide Arm/Group Description:

The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Overall Number of Participants Analyzed 158 157
Mean (Standard Error)
Unit of Measure: percentage change
6.9  (1.78) -2.0  (1.14)
Time Frame 12 months
Adverse Event Reporting Description Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge.
 
Arm/Group Title RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Hide Arm/Group Description

The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
All-Cause Mortality
RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   10/155 (6.45%)      8/157 (5.10%)    
Show Serious Adverse Events Hide Serious Adverse Events
RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/155 (50.32%)      44/157 (28.03%)    
Cardiac disorders     
Acute myocardial infarction  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Angina pectoris  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Atrial fibrillation  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Cardiac failure  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Cardio-respiratory arrest  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Cardiomyopathy  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Sinus tachycardia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Supraventricular tachycardia  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Tachycardia  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Colitis  1  1/155 (0.65%)  2 0/157 (0.00%)  0
Diverticulum  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Food poisoning  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Intestinal obstruction  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pneumoperitoneum  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Small intestinal obstruction  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Upper gastrointestinal haemorrhage  1  1/155 (0.65%)  1 1/157 (0.64%)  1
General disorders     
Adverse drug reaction  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Asthenia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Chest pain  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Medical device complication  1  5/155 (3.23%)  5 0/157 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Immune system disorders     
Allergy to metals  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Latex allergy  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Lung infection  1  2/155 (1.29%)  3 1/157 (0.64%)  1
Infections and infestations     
Abdominal sepsis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchitis  1  5/155 (3.23%)  5 2/157 (1.27%)  2
Bronchitis bacterial  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchopulmonary aspergillosis  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Diverticulitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Gastrointestinal infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Influenza  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Lung infection pseudomonal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pneumonia  1  31/155 (20.00%)  34 7/157 (4.46%)  9
Pneumonia staphylococcal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pseudomonas infection  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sepsis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Septic shock  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Subacute endocarditis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Tracheobronchitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Upper respiratory tract infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Wound infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Injury, poisoning and procedural complications     
Anastomatic leak  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Pneumothorax traumatic  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Rib fracture  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Spinal compression fracture  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Investigations     
Influenza A virus test positive  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Malnutrition  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Musculoskeletal chest pain  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Myalgia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign lymph node neoplasm  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bone neoplasm malignant  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Colon cancer  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Lung neoplasm  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Thyroid neoplasm  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Ischaemic stroke  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Sciatica  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Syncope  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Transient ischaemic attack  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Renal and urinary disorders     
Nephrolithiasis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Renal failure acute  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  3/155 (1.94%)  3 1/157 (0.64%)  2
Bronchial secretion retention  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Chronic obstructive pulmonary disease  1  43/155 (27.74%)  70 32/157 (20.38%)  47
Dyspnoea  1  5/155 (3.23%)  6 1/157 (0.64%)  1
Emphysema  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Haemoptysis  1  4/155 (2.58%)  4 0/157 (0.00%)  0
Pleural effusion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pneumothorax  1  15/155 (9.68%)  15 1/157 (0.64%)  1
Pulmonary embolism  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pulmonary haemorrhage  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Pulmonary venous thrombosis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory arrest  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Respiratory failure  1  5/155 (3.23%)  5 1/157 (0.64%)  1
Sleep apnoea syndrome  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Vascular disorders     
Aortic aneurysm  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Coeliac artery occlusion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Deep vein thrombosis  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Haemotoma  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Hypotension  1  1/155 (0.65%)  2 0/157 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RePneu Lung Volume Reduction Coil System Control Arm is Standard Medical Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   155/155 (100.00%)      142/157 (90.45%)    
Blood and lymphatic system disorders     
Anaemia  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Angina pectoris  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Atrial fibrillation  1  3/155 (1.94%)  3 2/157 (1.27%)  2
Cardiac failure  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Cardio-respiratory arrest  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Cardiomyopathy  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Left ventricular failure  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Palpitations  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sinus tachycardia  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Supraventricular extrasystoles  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Tachyarrhthmia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Tachycardia  1  3/155 (1.94%)  3 4/157 (2.55%)  5
Congenital, familial and genetic disorders     
Hydrocele  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  1/155 (0.65%)  2 0/157 (0.00%)  0
Vertigo  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Endocrine disorders     
Hypothyroidism  1  1/155 (0.65%)  1 3/157 (1.91%)  3
Eye disorders     
Cataract  1  1/155 (0.65%)  1 3/157 (1.91%)  3
Conjunctival haemorrhage  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Conjunctivitis  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Eye haemorrhage  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Glaucoma  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Abdominal pain  1  6/155 (3.87%)  6 1/157 (0.64%)  1
Abdominal pain lower  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Colitis  1  1/155 (0.65%)  2 0/157 (0.00%)  0
Constipation  1  2/155 (1.29%)  3 0/157 (0.00%)  0
Dental caries  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Diarrhoea  1  3/155 (1.94%)  3 2/157 (1.27%)  2
Diverticulum  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Dry mouth  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Dyspepsia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Dysphagia  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Food poisoning  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Gastroesophageal reflux disease  1  5/155 (3.23%)  5 1/157 (0.64%)  1
Intestinal obstruction  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Nausea  1  4/155 (2.58%)  4 1/157 (0.64%)  1
Pneumoperitoneum  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Rectal haemorrhage  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Small intestinal obstruction  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Tooth disorder  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Tooth fracture  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Tooth loss  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Toothache  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Upper gastrointestinal haemorrhage  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Vomiting  1  1/155 (0.65%)  1 0/157 (0.00%)  0
General disorders     
Adverse drug reaction  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Asthenia  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Chest discomfort  1  20/155 (12.90%)  30 1/157 (0.64%)  1
Chest pain  1  10/155 (6.45%)  14 4/157 (2.55%)  4
Face oedema  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Fatigue  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Hyperthermia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Influenza like illness  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Injection site extravasation  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Medical device complication  1  7/155 (4.52%)  8 0/157 (0.00%)  0
Medical device pain  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Non-cardiac chest pain  1  21/155 (13.55%)  28 0/157 (0.00%)  0
Oedema  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Oedema peripheral  1  11/155 (7.10%)  11 4/157 (2.55%)  4
Pain  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Pyrexia  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Cholecystitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Cholelithiasis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Hyperbilirubinemia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Allergy to metals  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Drug hypersensitivity  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Hypersensitivity  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Latex allergy  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Seasonal allergy  1  2/155 (1.29%)  2 2/157 (1.27%)  2
Infections and infestations     
Abdominal sepsis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Acute sinusitis  1  1/155 (0.65%)  2 2/157 (1.27%)  2
Bronchiolitis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Bronchitis  1  21/155 (13.55%)  31 25/157 (15.92%)  32
Bronchitis bacterial  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchitis viral  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Bronchopulmonary aspergillosis  1  4/155 (2.58%)  4 0/157 (0.00%)  0
Candidiasis  1  5/155 (3.23%)  5 3/157 (1.91%)  4
Cellulitis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Chronic sinusitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Clostridium difficile colitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Cystitis  1  1/155 (0.65%)  1 2/157 (1.27%)  3
Diverticulitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Endophthalmitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Ersipelas  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Fungal infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Furuncle  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Gastroenteritis  1  2/155 (1.29%)  2 2/157 (1.27%)  2
Gastroenteritis viral  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Gastrointestinal infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Gastrointestinal viral infection  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Genital abscess  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Herpes simplex  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Herpes zoster  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Infected bites  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Infectious disease carrier  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Influenza  1  5/155 (3.23%)  5 3/157 (1.91%)  3
Laryngitis fungal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Lower respiratory tract infection  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Lung infection  1  2/155 (1.29%)  4 2/157 (1.27%)  2
Lung infection pseudomonal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Nasopharyngitis  1  10/155 (6.45%)  13 6/157 (3.82%)  6
Onychomycosis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Oral candidiasis  1  10/155 (6.45%)  13 4/157 (2.55%)  6
Oral fungal infection  1  1/155 (0.65%)  2 2/157 (1.27%)  2
Oral herpes  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Orchitis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Pharyngitis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pneumonia  1  36/155 (23.23%)  44 12/157 (7.64%)  14
Pneumonia staphylococcal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pseudomonas bronchitis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Pseudomonas infection  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory monoliasis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory tract infection  1  1/155 (0.65%)  1 1/157 (0.64%)  2
Rhinitis  1  2/155 (1.29%)  2 5/157 (3.18%)  5
Sepsis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Septic shock  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Sinusitis  1  4/155 (2.58%)  4 8/157 (5.10%)  12
Skin infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Sputum purulent  1  1/155 (0.65%)  1 2/157 (1.27%)  2
Subacute endocarditis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Tinea infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Tooth abscess  1  0/155 (0.00%)  0 1/157 (0.64%)  2
Tracheobronchitis  1  3/155 (1.94%)  4 1/157 (0.64%)  1
Upper respiratory tract infection  1  9/155 (5.81%)  10 9/157 (5.73%)  9
Urinary tract infection  1  5/155 (3.23%)  8 6/157 (3.82%)  6
Volvovaginal mycotic infection  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Wound infection  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Injury, poisoning and procedural complications     
Anastomotic leak  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Contusion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Fall  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Laceration  1  4/155 (2.58%)  4 2/157 (1.27%)  2
Muscle rupture  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Muscle strain  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Pneumothorax traumatic  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Post procedural complication  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Procedural complication  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Procedural hemorrhage  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Procedural nausea  1  2/155 (1.29%)  3 0/157 (0.00%)  0
Procedural pain  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Rib fracture  1  4/155 (2.58%)  4 0/157 (0.00%)  0
Road traffic accident  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Skin wound  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Spinal compression fracture  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Tooth injury  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Upper limb fracture  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Wound  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Investigations     
Antibiotic resistant Staphylococcus test positive  1  1/155 (0.65%)  1 0/157 (0.00%)  0
C-reactive protein increased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Eosinophil count increased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Influenza A virus test positive  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Neutrophil count increased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Oxygen saturation decreased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Platelet count increased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sputum abnormal  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Weight decreased  1  2/155 (1.29%)  2 3/157 (1.91%)  3
Metabolism and nutrition disorders     
Dehydration  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Diabetes mellitus  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Gout  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Hyperglycaemia  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Hyperlipidaemia  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Hypokalaemia  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Malnutrition  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Overweight  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  2/155 (1.29%)  2 2/157 (1.27%)  2
Arthropathy  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Back pain  1  6/155 (3.87%)  7 3/157 (1.91%)  3
Bursitis  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Flank pain  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Intervertebral disc degeneration  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Muscle spasms  1  2/155 (1.29%)  2 3/157 (1.91%)  3
Musculoskeletal chest pain  1  5/155 (3.23%)  5 1/157 (0.64%)  1
Musculoskeletal pain  1  5/155 (3.23%)  5 0/157 (0.00%)  0
Myalgia  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Myalgia intercostal  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Neck pain  1  4/155 (2.58%)  4 1/157 (0.64%)  1
Osteoarthritis  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Pain in extremity  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Rotator cuff syndrome  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Colon cancer  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Lipoma  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Bone neoplasm malignant  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Lung neoplasm  1  11/155 (7.10%)  11 1/157 (0.64%)  1
Squamous cell carcinoma  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Squamous cell carcinoma of skin  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Thyroid neoplasm  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Convulsion  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Dizziness  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Headache  1  18/155 (11.61%)  23 0/157 (0.00%)  0
Ischaemic stroke  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Peripheral paralysis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Radiculopathy  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sciatica  1  1/155 (0.65%)  1 3/157 (1.91%)  3
Somnolence  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Syncope  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Tension headache  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Transient ischaemic attack  1  0/155 (0.00%)  0 2/157 (1.27%)  2
VIIth nerve paralysis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Psychiatric disorders     
Anxiety  1  3/155 (1.94%)  3 4/157 (2.55%)  4
Delirium  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Depression  1  3/155 (1.94%)  3 4/157 (2.55%)  5
Insomnia  1  2/155 (1.29%)  2 2/157 (1.27%)  2
Major depression  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Panic attack  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Somnambulism  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Renal and urinary disorders     
Cystitis haemorrhagic  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Dysuria  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Haematuria  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Hypertonic bladder  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Nephrolithiasis  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Renal failure acute  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Urinary incontinence  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Urinary retention  1  6/155 (3.87%)  6 1/157 (0.64%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Cervix haemorrhage uterine  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Gynaecomastia  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Prostatitis  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  3/155 (1.94%)  3 1/157 (0.64%)  2
Asthma  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchial disorder  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchial secretion retention  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Bronchitis chronic  1  1/155 (0.65%)  1 1/157 (0.64%)  2
Bronchospasm  1  4/155 (2.58%)  4 0/157 (0.00%)  0
Chronic obstructive pulmonary disease  1  108/155 (69.68%)  288 91/157 (57.96%)  185
Cough  1  26/155 (16.77%)  39 3/157 (1.91%)  3
Dysaesthesia pharynx  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Dysphonia  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Dyspnoea  1  33/155 (21.29%)  41 12/157 (7.64%)  15
Dyspnoea exertional  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Emphysema  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Epistaxis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Haemoptysis  1  91/155 (58.71%)  140 0/157 (0.00%)  0
Hypoxia  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Increased upper airway secretion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Lung consolidation  1  3/155 (1.94%)  3 0/157 (0.00%)  0
Lung disorder  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Lung infiltration  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Nasal congestion  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Nasal discomfort  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Oropharyngeal pain  1  12/155 (7.74%)  16 4/157 (2.55%)  4
Pleural effusion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pleuritic pain  1  5/155 (3.23%)  6 0/157 (0.00%)  0
Pneumothorax  1  18/155 (11.61%)  18 1/157 (0.64%)  1
Productive cough  1  1/155 (0.65%)  1 2/157 (1.27%)  3
Pulmonary congestion  1  6/155 (3.87%)  7 1/157 (0.64%)  1
Pulmonary embolism  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Pulmonary haemorrhage  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Pulmonary venous thrombosis  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory arrest  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Respiratory disorder  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory failure  1  5/155 (3.23%)  5 1/157 (0.64%)  1
Respiratory tract haemorrhage  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Respiratory tract irritation  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Rhinitis allergic  1  1/155 (0.65%)  1 2/157 (1.27%)  2
Rhinorrhoea  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sinus congestion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sleep apnoea syndrome  1  1/155 (0.65%)  1 2/157 (1.27%)  2
Sputum discolored  1  2/155 (1.29%)  4 0/157 (0.00%)  0
Sputum increased  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Sputum retention  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Throat irritation  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Wheezing  1  14/155 (9.03%)  22 1/157 (0.64%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Dermal cyst  1  0/155 (0.00%)  0 2/157 (1.27%)  2
Dry skin  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Erythema  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Livedo reticularis  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Rash  1  1/155 (0.65%)  1 1/157 (0.64%)  1
Rash erythematous  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Rosacea  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Skin ulcer  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Swelling face  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Surgical and medical procedures     
Sinus operation  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Vascular disorders     
Aortic aneurysm  1  0/155 (0.00%)  0 1/157 (0.64%)  1
Coeliac artery occlusion  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Deep vein thrombosis  1  2/155 (1.29%)  2 0/157 (0.00%)  0
Haemotoma  1  2/155 (1.29%)  2 1/157 (0.64%)  1
Hypertension  1  5/155 (3.23%)  5 2/157 (1.27%)  2
Hypotension  1  6/155 (3.87%)  7 0/157 (0.00%)  0
Phlebitis superficial  1  1/155 (0.65%)  1 0/157 (0.00%)  0
Venous insufficiency  1  1/155 (0.65%)  1 0/157 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ashley Burns
Organization: PneumRx
Phone: +1 650 625 8910 ext 6122
EMail: Ashley.Burns@btgplc.com
Layout table for additonal information
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01608490     History of Changes
Other Study ID Numbers: CLN0009
First Submitted: May 26, 2012
First Posted: May 31, 2012
Results First Submitted: April 25, 2017
Results First Posted: June 27, 2017
Last Update Posted: August 21, 2019