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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo Spiromax; Drug: Albuterol Spiromax

Study type: Interventional

Funder types: Industry

Identifiers

NCT01218009

ABS-AS-306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 331 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 2 patient groups, including a placebo group

Albuterol Spiromax

Experimental 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).

Treatment:

Drug: Albuterol Spiromax

Placebo Spiromax

Placebo Comparator group

Description:

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).

Treatment:

Drug: Albuterol Spiromax

Drug: Placebo Spiromax