ProAir Digihaler in COPD Disease Management: A Real World Study

The trial is an unblinded open label single center study designed to identify trends in Peak Inspiratory Flow (PIF) rates and Rescue Albuterol Inhaler usage (Inhalations) that associate with disease deterioration as defined by worsening of symptoms and reduced lung function in patients with COPD.

The study will consist of a run-in period of approximately 2 weeks, a treatment period of 6 months and a follow-up period of 1 week. Twenty (20) patients with COPD requiring intermittent short acting beta agonist (SABA) rescue inhaler usage, but not requiring frequent SABA nebulizer rescue usage, will be enrolled.

After signing informed consent, patients will undergo a screening evaluation. During the run-in period, patients will continue on their COPD maintenance treatments, while discontinuing all previously prescribed periodic use rescue medications. Upon completion of screening, all patients will be dispensed a ProAir Digihaler to be used exclusively as their rescue medication throughout the duration of the study. During the run-in period all rescue inhaler usage will be electronically monitored and patient data from the Digihaler Dashboard will be downloaded every other business day basis (Monday, Wednesday and Friday).

At the completion of at least 2 weeks of run-in (with a minimum of at least 8 rescue inhaler usages) and with documentation of stable clinical status throughout run-in, the patient will return for baseline testing; including vital signs, health related quality of life and Anthonisen Exacerbation questionnaires, pre and post bronchodilator spirometry and 6-minute walk testing (see table/flow chart). Average Peak Inspiratory Flow (Baseline PIF) and average Number of Rescue Inhalations per day (Baseline Inhalations) will be determined from the Digihaler Dashboard Data downloads during run-in.

In the event that the patient does not meet number of rescue inhaler usages or does not have a stable clinical status during run-in, an additional 2 weeks of run-in may be obtained. If at the end of the extended run-in period so that Baseline PIF and Baseline Inhalations cannot be determined or the patient continues to be clinically unstable, the patient will be discontinued from the study. If the patient has an upper respiratory tract infection or COPD exacerbation during run-in, they will also be discontinued from the study. Patients may be re-screened one time at a later date, when stable.

Once run-in and baseline testing are complete, all patients will continue on their maintenance COPD medications and use the ProAir Digihaler rescue SABA exclusively for the next 6 months. Patients will be provided with paper forms of the CAT, BCSS and Anthonisen Exacerbation criteria, to be completed at home on a weekly basis and mailed to the research center upon completion).

Throughout the treatment period, all rescue inhaler usage will be electronically transmitted to, monitored at and downloaded from the Digihaler Dashboard by the research center on every other business day basis (Monday, Wednesday and Friday). At the completion of each Digihaler Dashboard Data Download, comparisons of Daily PIF (average PIF of all rescue inhalations in a day) and Daily Inhalations (number of rescue inhalations in a day) to Baseline PIF and Baseline Inhalations will be made.

All patients with Daily Inhalations exceeding Baseline Inhalations by ≥4 Inhalations per day and/or with a Daily PIF ≤80% of Baseline PIF for 2 consecutive days will be DEFINED as "at risk". For each "at risk" event, the patient will be contacted, their health status reviewed, and CAT and Anthonisen Exacerbation questionnaires will be administered. Based on symptoms, patients may also be advised to seek additional medical care.

All patients will be contacted on a monthly basis, irrespective of "risk" findings and seen in person every 3 months. All medication usage (including ProAir Digihaler medication usage), changes in medical care, healthcare contacts and usage, and any adverse events will be recorded. All office records for the intervening time period will be reviewed and Information for any non-office healthcare contacts and usage will be requested to provide detailed clinical information for comparison to Digihaler usage records.

At months 3 and 6 on treatment, all subjects will return to the research center, where vital signs, Anthonisen Exacerbation and CAT questionnaires, and post bronchodilator spirometry will be assessed. All medication usage (including ProAir Digihaler medication usage), changes in medical care, healthcare contacts and usage, and any adverse events will be recorded. All office records for the intervening time period will be reviewed and Information for any non-office healthcare contacts and usage will be requested to provide detailed clinical information for comparison to Digihaler usage records. Three (3) new ProAir Digihalers will be dispensed at month 3.

Throughout the treatment period, all rescue inhaler usage will be electronically monitored and downloaded from the Digihaler Dashboard by the research center on an every other business day basis (Monday, Wednesday and Friday). At the completion of each Digihaler Dashboard Data Download, comparisons of Daily PIF (average PIF of all rescue inhalations in a day) and Daily Inhalations (number of rescue inhalations in a day) to Baseline PIF and Baseline Inhalations will be made.

All patients with Daily Inhalations exceeding Baseline Inhalations by ≥4 Inhalations per day and/or with a Daily PIF ≤80% of Baseline PIF for 2 consecutive days will be DEFINED as "at risk". For each "at risk" event, the patient will be contacted, their health status reviewed, and CAT and Anthonisen Exacerbation questionnaires will be administered. Based on symptoms, patients may also be advised to seek additional medical care.

At the conclusion of the 6-month treatment period the patients will return to the research center for a final visit, returning all study medication not previously returned. The patient will be advised to resume usage of their prior rescue inhaler medication at that time. A telephone call will be made to the patient 1 week after their final in-person visit, to assess vital status and any adverse events that may have occurred subsequent to discontinuing the ProAir Digihaler.