The purpose of this research study is to determine how safe and effective a combined investigational inhaled medication is when taken for a long period of time compared to taking the individual components of that drug in the treatment of patients with chronic obstructive pulmonary disease (COPD).

This study is for males and females at least 40 years of age who have a diagnosis of COPD and meet spirometry criteria.

Inclusion/Exclusion Criteria:

• Subjects must have greater than a 10 pack year smoking history
• Current and former smokers will be accepted
• Known significant disease other than COPD will not be permitted
• Subjects cannot be or become pregnant during the study
• Regular use of daytime oxygen therapy for greater than 1 hour a day will not be permitted
• Pulmonary rehabilitation in the 6 weeks prior to visit 1 or current participation will not be permitted

The total duration of participation, including follow up will be approximately 55 weeks. There will be a total of 12 clinic visits conducted on an outpatient basis. Visits will consist of spirometry, physical examinations, vital signs, laboratory examinations, EKGs and the completion of questionnaires. All study related care including study medication will be provided to participants at no cost. Subjects may be reimbursed for their time and certain travel expenses.

23 week study comparing an oral investigational medication versus placebo (inactive substance) administered once daily in male and female subjects 18 years of age and older.

Inclusion Criteria:

• Have access to a touch-tone phone for the duration of the study to complete daily diary calls.
• Abdominal pain or discomfort that has 2 or more of the following for at least 12 weeks, which need not be consecutive, in the 12 months before the Screening Visit:
  • Relieved with defecation
  • Onset associated with a change in frequency of stool
  • Onset associated with a change in appearance of stool
• Fewer than 3 bowel movements a week, without the use of laxatives, and 1 or more of the following symptoms for at least 12 weeks, which need not be consecutive, in the 12 months before Screening Visit:
  • Straining during more than 25% of bowel movements
  • Lumpy or hard stools during more than 25% of bowel movements
  • Sensation of incomplete evacuation during more than 25% of bowel movements
• Be willing to discontinue laxative use during the study visit in favor of the study-defined rescue medication

Exclusion Criteria:

• Report loose or watery stools for more than 25% of bowel movements during the 12 weeks prior to screening.
• Bariatric surgery (surgery for obesity), surgery of the abdomen, pelvis or retroperitoneal structures 6 months prior to Screening. Appendectomy or cholecystectomy 60 days prior to Visit 1.
• Gastrointestinal bleeding, iron deficient anemia, colitis, diverticulits, chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis or active peptic ulcer disease.
• Use of narcotics, non steroidal anti-inflammatory medication for abdominal pain or discomfort, or any medication used for weight loss.

Diabetes Screening
October 04
11AM-4PM
Kmart Pharmacy-Panama City
FREE

Cholesterol and Diabetes Screening
October 05
1PM-6PM
Winn Dixie Pharmacy-Crestview
FREE

Amplified Phone Distribution
October 07
10A-Noon
Jackson County Library-Mariana
FREE

Friday Fest
October 07
6PM-10PM
Down Town Panama City
Contact number 785-2554
Admission is FREE

“Art-Tique” Arts and Antique Walk
October 08
Noon to 6PM
Downtown Panama City
Contact Number: 850-785-2554

NAMI WALK
October 08
National Alliance on Mental Illness
Walk for Mental Illness Awareness Week
Sheffield Park, Lynn Haven
Registration: 9:30AM
Walk Begins: 10AM
Walk followed by picnic lunch, speeches, exhibits and music

Take Charge of Your Diabetes
October 10 -Pre Assessment
UF/IFAS Bay County Extension Office
2728 East 14th Street, Panama City
8 week class with numerous topics for Type 2 Diabetes
$75.00
Contact Number: 850-784-6105

Quit Smoking Now!
October 12
Gulf Coast Medical Center “The Learning Center”
2024 State Avenue Panama City
Noon-1PM weekly (6 total sessions)
FREE class and support group
FREE nicotine replacement therapy for participants
Contact: Wendy Barbero 850-747-7970 or wendy.barbero@hcahealthcare.com

Kaleidoscope Theater-”I’ll Be Back Before Midnight”
October 14-30
Various showtimes
207 East 24th Street, Panama City
Contact: 265-3226 for showtimes and tickets

Making Strides Against Breast Cancer 5K Walk
October 15
7AM Registration, 8AM Walk
Aaron Bessant @Pier Park
For More Information: www.putonyourpinkbra.com/panama city

Type 2 Diabetes Support Group
October 17
10AM-11AM
HealthPlex Community Room
Contact number: Jo Colville, 913-6913

FREE Glucose Screening
October 19
9AM-Noon
Bay Medical Diagnostics
Contact number: Jo Colville, 770-3518
No need to fast and no appointment necessary

Haunted Trail and Pumpkin Patch
October 21-22
Science and Discovery Center
(Formally Junior Museum)
Contact Number: 850-769-6128

Jazz by the Bay Festival
October 22-23
Music begins at 6:30 PM Friday
Resumes at Noon on Saturday until 7PM

Halloween Party
October 28
6:30 until the “witching” hours
Panama City Beach Senior Center

Boo at the Beach
October 29
Pier Park
Spooktacular Halloween Fun

Zoo Boo
October 29
ZooWorld
Trick or Treating at the Zoo

Malloween
October 31
Pier Park
Trick or Treating at Pier Park

This is a research study for chronic idiopathic constipation. Subjects who meet the inclusion criteria will be entered into up to a 9 day treatment period. Patients will either receive the product under study or the marketed equivalent or placebo. Medication will be administered orally twice daily.

Inclusion Criteria

• Male and non-pregnant females 18 years of age and older
• Chronic idiopathic constipation defined as, on average <3 bowel movements per week for the past 6 months
• Confirmation of chronic constipation by a daily diary during the 14 day lead-in period

Exclusion Criteria

• Pregnancy or breast feeding
• Documented bowel obstruction
• Crohn’s disease, ulcerative colitis
• History of bowel resection
• Regular use of medications known to cause constipation
• Unstable hypothyroidism, Parkinson’s disease, multiple sclerosis or spinal cord disorder
• Any hospitalization for any gastrointestinal or abdominal surgical procedure 3 months prior to dosing