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

Asthma Clinical Trial

Official title:

A Multi-Center 52-Week Study to Assess the Safety of an Albuterol Dry-powder Inhaler in Subjects With Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01218009
• Other study ID #: ABS-AS-306
• Status: Terminated
• Phase: Phase 3
• First received: October 7, 2010
• Last updated: May 1, 2015
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.

Description:

The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening.

• Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration

• General good health

• Capable of understanding the requirements, risks, and benefits of study participation

• Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years

• Other criteria apply

Exclusion Criteria:

• Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit

• Participation in any investigational drug trial within 30 days preceding the screening visit

• A known hypersensitivity to albuterol or any of the excipients in the formulations.

• History of severe milk protein allergy

• History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.

• Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications

• Inability to tolerate or unwillingness to comply with the protocol requirements.

• History of life-threatening asthma

• Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids

• History of life-threatening asthma

• Other criteria apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo Spiromax
Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
• Albuterol Spiromax
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm. The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	Bellevue	Nebraska
United States	Teva Clinical Study Site	Boys Town	Nebraska
United States	Teva Clinical Study Site	Burke	Virginia
United States	Teva Clinical Study Site	Canton	Ohio
United States	Teva Clinical Study Site	Centennial	Colorado
United States	Teva Clinical Study Site	Cincinnati	Ohio
United States	Teva Clinical Study Site	Denver	Colorado
United States	Teva Clinical Study Site	El Paso	Texas
United States	Teva Clinical Study Site	Eugene	Oregon
United States	Teva Clinical Study Site	Gainesville	Georgia
United States	Teva Clinical Study Site	Greenfield	Wisconsin
United States	Teva Clinical Study Site	High Point	North Carolina
United States	Teva Clinical Study Site	Los Angeles	California
United States	Teva Clinical Study Site	Louisville	Kentucky
United States	Teva Clinical Study Site	Miami	Florida
United States	Teva Clinical Study Site	Minneapolis	Minnesota
United States	Teva Clinical Study Site	New Braunfels	Texas
United States	Teva Clinical Study Site	Plymouth	Minnesota
United States	Teva Clinical Study Site	Portland	Oregon
United States	Teva Clinical Study Site	Raleigh	North Carolina
United States	Teva Clinical Study Site	Rochester	New York
United States	Teva Clinical Study Site	Rockville Centre	New York
United States	Teva Clinical Study Site	San Antonio	Texas
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	Scottsdale	Arizona
United States	Teva Clinical Study Site	Seattle	Washington
United States	Teva Clinical Study Site	Skillman	New Jersey
United States	Teva Clinical Study Site	St. Louis	Missouri
United States	Teva Clinical Study Site	Sylvania	Ohio
United States	Teva Clinical Study Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Treatment-Emergent Adverse Events	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.	Day 1 to Day 49 (study termination)	Yes
Primary	Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator	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.	Days -15 to -8 (Screening), Week 12, Week 52	Yes
Primary	Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator	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.	Days -15 to -8 (Screening), Week 12, Week 52	Yes
Primary	Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator	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.	Days -15 to -8 (Screening), Week 12, Week 52	Yes
Primary	Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator	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.	Days -15 to -8 (Screening), Week 12, Week 52	Yes