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Trial record 21 of 857 for:    ALBUTEROL

A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

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ClinicalTrials.gov Identifier: NCT01218009
Recruitment Status : Terminated (Change to study required.)
First Posted : October 8, 2010
Results First Posted : May 20, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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: Placebo Spiromax
Drug: Albuterol Spiromax
Enrollment 331
Recruitment Details  
Pre-assignment Details Four hundred fifty-two patients were screened and 331 randomized into the study.
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Period Title: Overall Study
Started 166 165
Completed 0 0
Not Completed 166 165
Reason Not Completed
Protocol Violation             2             1
Withdrawal by Subject             3             1
Sponsor terminated study             161             163
Arm/Group Title Albuterol Spiromax Placebo Spiromax Total
Hide Arm/Group Description Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). Total of all reporting groups
Overall Number of Baseline Participants 166 165 331
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 165 participants 331 participants
37.9  (14.07) 38.0  (14.91) 37.9  (14.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 331 participants
Female
105
  63.3%
122
  73.9%
227
  68.6%
Male
61
  36.7%
43
  26.1%
104
  31.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 331 participants
White 140 132 272
Black 19 28 47
Asian 4 1 5
North American or Alaska Native 1 0 1
Other 2 4 6
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 165 participants 331 participants
Hispanic 20 21 41
Not Hispanic 146 144 290
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 166 participants 165 participants 331 participants
66.1  (3.59) 65.7  (3.86) 65.9  (3.73)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 166 participants 165 participants 331 participants
184  (49.7) 179  (48.2) 182  (48.9)
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide Description Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame Day 1 to Day 49 (study termination)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 166 165
Measure Type: Number
Unit of Measure: participants
Any adverse event 59 58
Treatment-related adverse event 3 3
Withdrawn from study due to adverse event 0 0
Serious adverse event 1 1
Treatment-related serious adverse event 0 0
Mild adverse event 29 32
Moderate adverse event 35 29
Severe adverse event 2 4
AE class: Infections and infestations 31 34
AE class: Respiratory, thoracic and mediastinal 12 11
AE class: Gastrointestinal 9 5
AE class: Nervous system 7 6
AE class: Injury, poisoning and procedural compli 4 2
AE class: Investigations 3 3
AE class: Musculoskeletal and connective tissue 2 4
AE class: Renal and urinary 2 1
AE class: Ear and labyrinth 2 1
AE class: Skin and subcutaneous tissue 2 0
AE class: General and administrative site conditi 1 1
AE class: Psychiatric 1 1
AE class: Social circumstances 1 0
AE class: Cardiac 0 2
AE class: Eye 0 1
AE class: Blood and lymphatic system 0 1
Neoplasm benign, malignant + unspecified 0 1
2.Primary Outcome
Title Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator
Hide Description A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.
Time Frame Days -15 to -8 (Screening), Week 12, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. The study was terminated prior to the during study evaluations.
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator
Hide Description Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.
Time Frame Days -15 to -8 (Screening), Week 12, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. The study was terminated prior to the during study evaluations.
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator
Hide Description A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.
Time Frame Days -15 to -8 (Screening), Week 12, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. The study was terminated prior to the during study evaluations.
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator
Hide Description Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.
Time Frame Days -15 to -8 (Screening), Week 12, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. The study was terminated prior to the during study evaluations.
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Post-Hoc Outcome
Title Blood Pressure at Screening and End of Study
Hide Description Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.
Time Frame Days -15 to -8 (Screening), up to Day 49 (End of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 166 165
Mean (Standard Deviation)
Unit of Measure: mmHg
Screening Diastolic BP (n=166, 165) 75.5  (9.24) 75.2  (9.08)
End of Study Diastolic BP (n=164, 164) 75.7  (9.54) 75.2  (8.79)
Screening Systolic BP (n=166, 165) 119.4  (13.39) 118.0  (13.70)
End of Study Systolic BP (n=164, 164) 118.4  (13.50) 118.2  (12.99)
7.Post-Hoc Outcome
Title Pulse at Screening and End of Study
Hide Description Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.
Time Frame Days -15 to -8 (Screening), up to Day 49 (End of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Overall Number of Participants Analyzed 166 165
Mean (Standard Deviation)
Unit of Measure: beats/minute
Screening (n=166, 165) 71.0  (8.57) 71.8  (10.03)
End of study (n=164, 164) 72.1  (9.34) 73.0  (9.48)
Time Frame Day 1 to Day 49 (study termination)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Spiromax Placebo Spiromax
Hide Arm/Group Description Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN). Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
All-Cause Mortality
Albuterol Spiromax Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Spiromax Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   1/166 (0.60%)   1/165 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal adenocarcinoma  1  0/166 (0.00%)  1/165 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/166 (0.60%)  0/165 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Albuterol Spiromax Placebo Spiromax
Affected / at Risk (%) Affected / at Risk (%)
Total   16/166 (9.64%)   20/165 (12.12%) 
Infections and infestations     
Nasopharyngitis  1  6/166 (3.61%)  10/165 (6.06%) 
Upper respiratory tract infection  1  10/166 (6.02%)  11/165 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01218009     History of Changes
Other Study ID Numbers: ABS-AS-306
First Submitted: October 7, 2010
First Posted: October 8, 2010
Results First Submitted: May 1, 2015
Results First Posted: May 20, 2015
Last Update Posted: May 20, 2015