Trial Outcomes & Findings for A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects (NCT NCT02150499)

Results Overview

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Week 1

Results posted on

2016-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	18.6 months STANDARD_DEVIATION 10.21 • n=93 Participants	17.1 months STANDARD_DEVIATION 12.75 • n=4 Participants	17.8 months STANDARD_DEVIATION 11.23 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	9 participants n=4 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: Week 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome measures
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.	4 Number of Adverse Events	6 Number of Adverse Events

PRIMARY outcome

Timeframe: Week 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome measures
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.	0 Number of Serious Adverse Events	0 Number of Serious Adverse Events

PRIMARY outcome

Timeframe: Week 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome measures
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol n=9 Participants Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.	0 Number of Discontinuations	0 Number of Discontinuations

SECONDARY outcome

Timeframe: Day 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 minutes, 40 minutes, 60 minutes

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 minutes, 40 minutes, 60 minutes

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.

Outcome measures

Outcome data not reported

Adverse Events

Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA n=9 participants at risk Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol levalbuterol tartrate HFA inhalation aerosol placebo	Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol n=9 participants at risk Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol. levalbuterol tartrate HFA inhalation aerosol
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months
Respiratory, thoracic and mediastinal disorders Existaxis	11.1% 1/9 • Number of events 1 • three months	0.00% 0/9 • three months
Respiratory, thoracic and mediastinal disorders Stridor	11.1% 1/9 • Number of events 1 • three months	0.00% 0/9 • three months
Cardiac disorders Tachycardia	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months
Blood and lymphatic system disorders Lymphadenopathy	11.1% 1/9 • Number of events 1 • three months	0.00% 0/9 • three months
Gastrointestinal disorders Vomiting	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months
General disorders Chest pain	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months
Infections and infestations Pharyngitis	11.1% 1/9 • Number of events 1 • three months	0.00% 0/9 • three months
Nervous system disorders Termor	0.00% 0/9 • three months	11.1% 1/9 • Number of events 1 • three months

Additional Information

Respiratory Medical Director

Sunovion Pharmaceuticals Inc.

Phone: 1-866-503-6351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
Publication restrictions are in place

Restriction type: OTHER