Trial Outcomes & Findings for Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler (NCT NCT01196104)

NCT ID: NCT01196104

Last Updated: 2014-10-30

Results Overview

Change from Baseline in glycated hemoglobin at Week 16

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 39 participants
• Primary outcome timeframe: Baseline to Week 16
• Results posted on: 2014-10-30

Participant Flow

The FIrst Patient First Visit (FPFV) was September 21, 2010, and Last Patient Last Visit (LPLV) was August 25, 2011. Trial conducted in US. The study was terminated before completion of full enrollment for business reasons. Subjects already enrolled were allowed to complete the study to assess the safety of the titration algorithms.

After a 1 week to 5 week run-in period, subjects were randomized to receive either TI Inhalation Powder in combination with insulin glargine, or insulin aspart in combination with insulin glargine. 105 Screened/46 Eligible. 39 subjects were randomized; 59 screen failures and 7 were screened but not randomized.

Participant milestones

Measure	Technosphere Insulin + Insulin Glargine Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Study STARTED	19	20
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	Technosphere Insulin + Insulin Glargine Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	3	3
Overall Study Various	0	1

Baseline Characteristics

Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

Baseline characteristics by cohort

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient	Total n=37 Participants Total of all reporting groups
Age, Continuous	60.6 years FULL_RANGE 7.95 • n=5 Participants	58.1 years FULL_RANGE 10.67 • n=7 Participants	59.4 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
Duration of Diabetes	14.6 years FULL_RANGE 7.95 • n=5 Participants	15.6 years FULL_RANGE 10.67 • n=7 Participants	15.1 years n=5 Participants
Body Weight	100.9 kg FULL_RANGE 21.84 • n=5 Participants	100.8 kg FULL_RANGE 20.30 • n=7 Participants	100.9 kg n=5 Participants
Body Mass Index	33.2 kg/m2 FULL_RANGE 5.78 • n=5 Participants	33.3 kg/m2 FULL_RANGE 5.51 • n=7 Participants	33.2 kg/m2 n=5 Participants
HbA1c	7.76 % FULL_RANGE 1.097 • n=5 Participants	7.94 % FULL_RANGE 1.098 • n=7 Participants	7.85 % n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population, participants with data available at Baseline and Week 16

Change from Baseline in glycated hemoglobin at Week 16

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=16 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=14 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Change in HbA1c (%) From Baseline to Week 16	-1.2179 Percentage of total hemoglobin Standard Deviation 0.1468	-1.2652 Percentage of total hemoglobin Standard Deviation 0.1571

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks

Not analyzed due to early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Total number of times patients coughed once, intermittently or continuously (inclusive)

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Total Number of Cough Episodes	5 Cough episodes	0 Cough episodes

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation

Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:

• SMBG levels ≤ 36 mg/dL OR
• There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Severe Hypoglycemic Event Rate	0.01 Events / subject-month	0.34 Events / subject-month

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation

Nonsevere hypoglycemia is defined as a subject:

• SMBG levels < 70 mg/dL AND/OR
• Symptoms that are relieved by the self-administration of carbohydrates

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Mild or Moderate Hypoglycemic Event Rate	4.47 Events / subject-month	4.41 Events / subject-month

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Number of Subjects Reporting Cough Episodes

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Number of Subjects Reporting Cough Episodes	4 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Number of subjects reporting Intermittent Coughing Episodes

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Number of Subjects Reporting Intermittent Coughing Episodes	4 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Total number of times patients coughed only once

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Number of Single Coughing Episodes	1 Cough episodes	0 Cough episodes

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation	5 Cough episodes	0 Cough episodes

SECONDARY outcome

Timeframe: Baseline

Population: Safety Population

Baseline FEV1

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Baseline Forced Expiratory Volume in 1 Second (FEV1)	2.97 L Standard Deviation 0.63	2.83 L Standard Deviation 0.75

SECONDARY outcome

Timeframe: Week 16

Population: Safety Population, with data available at Week 16

Week 16 FEV1

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=14 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=15 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 16 Forced Expiratory Volume in 1 Second	2.91 L Standard Deviation 0.57	2.66 L Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population, with data available at Week 16

Week 16 Change from Baseline in FEV1

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=14 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=15 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second	-0.14 L Standard Deviation 0.32	-0.07 L Standard Deviation 0.27

SECONDARY outcome

Timeframe: Week 20 (Follow-up)

Population: Safety Population, with data available at Week 20

Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=13 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=14 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 20 (Follow-up) Forced Expiratory Volume in 1 Second	3.07 L Standard Deviation 0.55	2.86 L Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline to Week 20

Population: Safety Population, with data available at Week 20

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=13 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=14 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second	-0.07 L Standard Deviation 0.29	-0.05 L Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline

Population: Safety Population

Baseline FVC

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=19 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=18 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Baseline Forced Vital Capacity (FVC)	3.63 L Standard Deviation 0.78	3.48 L Standard Deviation 1.02

SECONDARY outcome

Timeframe: Week 16

Population: Safety Population, with data available at Week 16

Week 16 FVC

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=14 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=15 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 16 Forced Vital Capacity	3.61 L Standard Deviation 0.72	3.33 L Standard Deviation 0.98

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Safety Population, with data available at Week 16

Week 16 Change from Baseline FVC

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=14 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=15 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 16 Change From Baseline Forced Vital Capacity	-0.13 L Standard Deviation 0.34	-0.07 L Standard Deviation 0.36

SECONDARY outcome

Timeframe: Week 20

Population: Safety Population, with data available at Week 20

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=13 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=14 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 20 (Follow-up) Forced Vital Capacity	3.77 L Standard Deviation 0.73	3.57 L Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline to Week 20

Population: Safety Population, with data available at Week 20

Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC

Outcome measures

Measure	Technosphere Insulin + Insulin Glargine n=13 Participants Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient	Insulin Aspart + Insulin Glargine n=14 Participants Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity	-0.05 L Standard Deviation 0.35	-0.06 L Standard Deviation 0.38

Adverse Events

Technosphere® Insulin Inhalation Powder (TI)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Comparator

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Technosphere® Insulin Inhalation Powder (TI) n=19 participants at risk Insulin Glargine and Technosphere® Insulin Inhalation Powder Technosphere® Insulin Inhalation Powder Insulin Glargine	Comparator n=18 participants at risk Insulin Glargine and Insulin Aspart Insulin Aspart: Usual Care Insulin Glargine
Cardiac disorders Angina unstable	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Injury, poisoning and procedural complications Rib Fracture	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose

Other adverse events

Measure	Technosphere® Insulin Inhalation Powder (TI) n=19 participants at risk Insulin Glargine and Technosphere® Insulin Inhalation Powder Technosphere® Insulin Inhalation Powder Insulin Glargine	Comparator n=18 participants at risk Insulin Glargine and Insulin Aspart Insulin Aspart: Usual Care Insulin Glargine
Cardiac disorders Angina Pectoris	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Cardiac disorders Atrial Fibrillation	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Cardiac disorders Ventricular extrasystoles	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Endocrine disorders Hypothyroidism	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Eye disorders Mydriasis	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Eye disorders Vitreous haemorrhage	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Gastrointestinal disorders Abdominal pain upper	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Gastrointestinal disorders Diarrhea	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
General disorders Oedema	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
General disorders Oedema Peripheral	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Infections and infestations Upper Respiratory Tract Infection	21.1% 4/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Infections and infestations Ear Infection	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Infections and infestations Onychomycosis	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Infections and infestations Sinusitis	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Infections and infestations Urinary Tract Infection	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Infections and infestations Nasopharyngitis	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Infections and infestations Pharyngitis	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Investigations Blood Testosterone Decreased	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 2/19 • From first dose to 30d post last dose	11.1% 2/18 • From first dose to 30d post last dose
Musculoskeletal and connective tissue disorders Back Pain	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Musculoskeletal and connective tissue disorders Plantar Fasciitis	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Nervous system disorders Dizziness	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Nervous system disorders Headache	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Nervous system disorders Hypoaesthesia	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Psychiatric disorders Depression	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Renal and urinary disorders Renal Failure	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Cough	21.1% 4/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Sinus Congestion	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Throat Irritation	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Surgical and medical procedures Cataract Operation	0.00% 0/19 • From first dose to 30d post last dose	5.6% 1/18 • From first dose to 30d post last dose
Vascular disorders Hypertension	5.3% 1/19 • From first dose to 30d post last dose	0.00% 0/18 • From first dose to 30d post last dose

Additional Information

Chief Medical Officer

MannKind Corporation

Phone: 201-983-5000

Email: aboss@mannkindcorp.com

Results disclosure agreements

• Principal investigator is a sponsor employee MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.
• Publication restrictions are in place

Restriction type: OTHER