Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 75 study centers in Japan, from Aug 2016 to June 2018. This is an extension study of PT010006 and could take up to an additional 28 weeks.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized in a 2:2:1:1 scheme.

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID

Participant Flow:   Overall Study

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug BID
 STARTED  139 138 70 69
 COMPLETED  112 102 56 54
 NOT COMPLETED  27 36 14 15
  Withdrawal by Subject   15 13 8 7
  Adverse Event   10 12 4 6
  Physician Decision   2 5 1 0
  Lack of Efficacy   0 5 1 2
  Protocol Discontinuation Criteria   0 1 0 0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Japanese Safety Population

Reporting Groups

Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID

Baseline Measures

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug BID Total
Number of Participants
[units: Participants] 		139 138 70 69 416
Age Continuous
[units: Years]
Mean ± Standard Deviation		 69.4 ± 7.1 69.0 ± 6.1 69.7 ± 6.1 70.1 ± 6.8 69.5 ± 6.5
Sex: Female, Male
[units: Participants]
         
Female 9 12 2 1 24
Male 130 126 68 68 392
Ethnicity (NIH/OMB)
[units: ]
         
Hispanic or Latino 0 0 0 0 0
Not Hispanic or Latino 139 138 69 69 415
Unknown or Not Reported 0 0 1 0 1
Race (NIH/OMB)
[units: ]
         
American Indian or Alaska Native 0 0 0 0 0
Asian 139 138 70 69 416
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 0 0 0 0
White 0 0 0 0 0
More than one race 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0

Outcome Measures

1. Primary Outcome Measure: Incidence of post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values   [ Time Frame: 28 Weeks ]

Measure Type Primary
Measure Name Incidence of post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
Measure Description Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
Time Frame 28 Weeks
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Japanese Safety Population

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug Open Label Symbicort Turbuhaler 400/12 ug BID

Measured Values

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug
Number of Participants Analyzed
[units:participants]
 137 137 68 68
Incidence of post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
[units: Count of Participants]
        
ALT >3 x ULN 0 1 0 0
Total Bilirubin >2 x ULN 0 0 0 1
Potassium (mmol/L) >6.0 2 0 0 0
Glucose (mmol/L) >13.9 if Baseline is ≤10.0 0 1 1 1
Glucose (mmol/L) >16.7 if baseline is >10.0 0 1 0 0

No statistical analysis provided for Incidence of post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values

2. Primary Outcome Measure: Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs   [ Time Frame: 28 Weeks ]

Measure Type Primary
Measure Name Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Measure Description Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Time Frame 28 Weeks
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Japanese Safety Population

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug Open Label Symbicort Turbuhaler 400/12 ug BID

Measured Values

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug
Number of Participants Analyzed
[units:participants]
 139 138 70 69
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
[units: Particpants]
        
Systolic Blood Pressure >=180, Incr >=20 3 1 0 0
Systolic Blood Pressure, <=90, Decr >=20 4 1 1 1
Diastolic Blood Pressure, >=105 Incr, >=15 2 1 2 0
Diastolic Blood Pressure, <=50, Decr >=15 4 3 2 3
Tachycardia Event >=110, Incr >=15% 1 0 2 0
Bradycardia Event <=50, Decr >=15% 9 8 3 2

No statistical analysis provided for Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs

3. Primary Outcome Measure: Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values   [ Time Frame: 28 Weeks ]

Measure Type Primary
Measure Name Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Measure Description Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Time Frame 28 Weeks
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Japanese Safety Population

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug Open Label Symbicort Turbuhaler 400/12 ug BID

Measured Values

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug
Number of Participants Analyzed
[units:participants]
 139 138 70 69
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
[units: Participants]
        
>=500 if <500 msec at BL and change >=15 msec 1 0 0 0
>=530 if >=500 msec at BL and >=15 msec 0 0 0 0
>= 500 msec and >= 15 msec change from BL 1 0 0 0
Increase from baseline is >=60 msec 1 1 0 0
Value is >500 msec and increase >=60 msec 0 0 0 0

No statistical analysis provided for Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values

Serious Adverse Events

Time Frame Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks.
Additional Description The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID

Serious Adverse Events

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug BID
Total, serious adverse events        
# participants affected / at risk 21/139 (15.11%) 30/138 (21.74%) 11/70 (15.71%) 14/69 (20.29%)
Respiratory, thoracic and mediastinal disorders        
Chronic obstructive pulmonary disorder †        
# participants affected / at risk 7/139 (5.04%) 11/138 (7.97%) 2/70 (2.86%) 2/69 (2.90%)
# events 8 21 2 2
Respiratory, thoracic and mediastinal disorders        
Pneumothorax †        
# participants affected / at risk 0/139 (0.00%) 2/138 (1.45%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 3 1 0
Respiratory, thoracic and mediastinal disorders        
Acute respiratory failure †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Respiratory, thoracic and mediastinal disorders        
Interstitial lung disease †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Respiratory, thoracic and mediastinal disorders        
Pneumothorax spontaneous †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Respiratory, thoracic and mediastinal disorders        
Respiratory failure †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Infections and infestations        
Pneumonia †        
# participants affected / at risk 8/139 (5.76%) 3/138 (2.17%) 1/70 (1.43%) 2/69 (2.90%)
# events 8 3 1 2
Infections and infestations        
Pneumonia bacterial †        
# participants affected / at risk 2/139 (1.44%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 2 1 0 0
Infections and infestations        
Bronchitis †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Infections and infestations        
Bronchopulmonary aspergillosis †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Infections and infestations        
Gastroenteritis †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Infections and infestations        
Herpes zoster †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Infections and infestations        
Infectious pleural effusion †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Infections and infestations        
Influenza †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Infections and infestations        
Oropharyngeal candidiasis †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Infections and infestations        
Sepsis †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Infections and infestations        
Septic shock †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Colon cancer †        
# participants affected / at risk 1/139 (0.72%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 1 0 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Adenocarcinoma gastric †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Adenocarcinoma †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Gastric cancer †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Lymphoma †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Malignant neoplasm of thymus †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Prostate cancer †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Squamous cell carcinoma of lung †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Urethral cancer †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Cardiac disorders        
Acute myocardial infarction †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 2/69 (2.90%)
# events 0 0 0 2
Cardiac disorders        
Acute coronary syndrome †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Cardiac disorders        
Angina pectoris †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Cardiac disorders        
Angina unstable †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Cardiac disorders        
Arrhythmia †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Cardiac disorders        
Cardio-respiratory arrest †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Cardiac disorders        
Coronary artery disease †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Cardiac disorders        
Myocardial ischaemia †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Gastrointestinal disorders        
Large intestine polyp †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 2/69 (2.90%)
# events 0 0 1 2
Gastrointestinal disorders        
Colitis ischaemic †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Gastrointestinal disorders        
Gastric ulcer haemorrhage †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Gastrointestinal disorders        
Oesophageal rupture †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Gastrointestinal disorders        
Small intestinal obstruction †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Injury, poisoning and procedural complications        
Meniscus injury †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 2 0 0
Injury, poisoning and procedural complications        
Clavicle fracture †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Injury, poisoning and procedural complications        
Hand fracture †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Injury, poisoning and procedural complications        
Rib fracture †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Injury, poisoning and procedural complications        
Road traffic accident †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Injury, poisoning and procedural complications        
Thoracic vertebral fracture †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 1/70 (1.43%) 0/69 (0.00%)
# events 0 0 1 0
Injury, poisoning and procedural complications        
Wrist fracture †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Hepatobiliary disorders        
Cholangitis †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 2 0 0
Hepatobiliary disorders        
Cholecystitis acute †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Blood and lymphatic system disorders        
Disseminated intravascular coagulation †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Musculoskeletal and connective tissue disorders        
Rheumatoid arthritis †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Nervous system disorders        
Cerebral infarction †        
# participants affected / at risk 0/139 (0.00%) 1/138 (0.72%) 0/70 (0.00%) 0/69 (0.00%)
# events 0 1 0 0
Reproductive system and breast disorders        
Prostatitis †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Skin and subcutaneous tissue disorders        
Acute febrile neutrophilic dermatosis †        
# participants affected / at risk 1/139 (0.72%) 0/138 (0.00%) 0/70 (0.00%) 0/69 (0.00%)
# events 1 0 0 0
Vascular disorders        
Aortic aneurysm †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Lung Adenocarcinoma †        
# participants affected / at risk 0/139 (0.00%) 0/138 (0.00%) 0/70 (0.00%) 1/69 (1.45%)
# events 0 0 0 1
† Events were collected by systematic assessment
1 Term from vocabulary,  

Other Adverse Events

Time Frame Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks.
Additional Description The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.

Frequency Threshold

Threshold above which other adverse events are reported 5%

Reporting Groups

  Description
BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID

Other Adverse Events

  BGF MDI 320/14.4/9.6 ug GFF MDI 14.4/9.6 ug BFF MDI 320/9.6 ug Symbicort TBH 400/12 ug BID
Total, other (not including serious) adverse events        
# participants affected / at risk 82/139 (58.99%) 75/138 (54.35%) 40/70 (57.14%) 38/69 (55.07%)
Infections and infestations        
Nasopharyngitis †        
# participants affected / at risk 45/139 (32.37%) 43/138 (31.16%) 22/70 (31.43%) 24/69 (34.78%)
# events 69 57 33 30
Infections and infestations        
Bronchitis †        
# participants affected / at risk 14/139 (10.07%) 11/138 (7.97%) 8/70 (11.43%) 7/69 (10.14%)
# events 20 20 10 8
Infections and infestations        
Influenza †        
# participants affected / at risk 5/139 (3.60%) 6/138 (4.35%) 3/70 (4.29%) 6/69 (8.70%)
# events 5 6 3 6
Respiratory, thoracic and mediastinal disorders        
Upper Respiratory tract inflammation †        
# participants affected / at risk 5/139 (3.60%) 7/138 (5.07%) 5/70 (7.14%) 0/69 (0.00%)
# events 8 9 7 0
Respiratory, thoracic and mediastinal disorders        
Dysphonia †        
# participants affected / at risk 10/139 (7.19%) 1/138 (0.72%) 9/70 (12.86%) 3/69 (4.35%)
# events 10 1 9 3
Musculoskeletal and connective tissue disorders        
Muscle spasms †        
# participants affected / at risk 16/139 (11.51%) 6/138 (4.35%) 6/70 (8.57%) 3/69 (4.35%)
# events 16 6 7 3
Gastrointestinal disorders        
Constipation †        
# participants affected / at risk 6/139 (4.32%) 5/138 (3.62%) 4/70 (5.71%) 2/69 (2.90%)
# events 6 8 4 2
Skin and subcutaneous tissue disorders        
Eczema †        
# participants affected / at risk 1/139 (0.72%) 3/138 (2.17%) 4/70 (5.71%) 4/69 (5.80%)
# events 1 3 4 4
Infections and infestations        
Upper respiratory tract infection †        
# participants affected / at risk 10/139 (7.19%) 8/138 (5.80%) 1/70 (1.43%) 2/69 (2.90%)
# events 11 12 1 2
† Events were collected by systematic assessment
1 Term from vocabulary,  

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title: Paul M. Dorinsky, MD
Organization: AstraZeneca
Phone 1-877-240-9479 
E-mail: [email protected]
.