A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)

Teva Pharmaceuticals

Status: Completed

Conditions: Chronic Bronchitis; Asthma; Emphysema; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Albuterol

Study type: Observational

Funder types: Industry

Identifiers

NCT01302587

ABM-AS-307

Details and patient eligibility

About

This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.

Enrollment: 306 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent/assent
• General good health
• Asthma or COPD
• Capable of understanding the requirements, risks, and benefits of study participation.
• Able to demonstrate proper metered-dose inhaler use and technique.
• Other inclusion criteria apply

Exclusion criteria

• History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
• Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
• Is being treated with a long-acting β2-agonist alone.
• Is currently being treated with Ventolin HFA.
• Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
• Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
• Uncontrolled hypertension
• History of any adverse reaction to any component of the HFA-MDI formulation.
• Participation in any investigational drug study within the 30 days preceding the Screening Visit.
• Other exclusion criteria apply.

Trial design

306 participants in 1 patient group

Albuterol MDI

Description:

All participants in this study will receive an albuterol MDI inhaler.

Treatment:

Drug: Albuterol