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Trial record 66 of 857 for:    ALBUTEROL

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

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ClinicalTrials.gov Identifier: NCT02150499
Recruitment Status : Terminated
First Posted : May 30, 2014
Results First Posted : February 3, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: levalbuterol tartrate HFA inhalation aerosol
Drug: placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
Pediatric subjects birth to less than or equal to 48 months of age with reactive airways disease in an acute setting
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
9
 100.0%
9
 100.0%
18
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 9 participants 9 participants 18 participants
18.6  (10.21) 17.1  (12.75) 17.8  (11.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
6
  66.7%
5
  55.6%
11
  61.1%
Male
3
  33.3%
4
  44.4%
7
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9 9 18
1.Primary Outcome
Title The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.
Hide Description 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.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: Number of Adverse Events
4 6
2.Primary Outcome
Title The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.
Hide Description 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.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
0 0
3.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: Number of Discontinuations
0 0
4.Secondary Outcome
Title Change From Baseline in Pulmonary Score (Total Score) to End of Treatment
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Pulmonary Score (Total Score) After Each Dose
Hide Description 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.
Time Frame 20 minutes, 40 minutes, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose
Hide Description 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.
Time Frame 20 minutes, 40 minutes, 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number and Percentage of Subjects Determined to be Stabilized After Treatment
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame three months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Hide Arm/Group Description

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

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

All-Cause Mortality
Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/9 (22.22%)      2/9 (22.22%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/9 (11.11%)  1 0/9 (0.00%)  0
Cardiac disorders     
Tachycardia * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Vomiting * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Chest pain * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Pharyngitis * 1  1/9 (11.11%)  1 0/9 (0.00%)  0
Nervous system disorders     
Termor * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
Cough * 1  0/9 (0.00%)  0 1/9 (11.11%)  1
Existaxis * 1  1/9 (11.11%)  1 0/9 (0.00%)  0
Stridor * 1  1/9 (11.11%)  1 0/9 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
EMail: clinicaltrialsdisclousre@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02150499     History of Changes
Other Study ID Numbers: SEP051-361
First Submitted: May 27, 2014
First Posted: May 30, 2014
Results First Submitted: November 18, 2015
Results First Posted: February 3, 2016
Last Update Posted: April 8, 2016