Shortness Of Breath Questionnaire Validation Study
Shortness Of Breath Questionnaire Validation Study
This study will last for approximately 8 weeks and will involve 4 visits. The study is being
 carried out to validate a shortness of breath questionnaire
Inclusion criteria:

 -  Diagnosis of COPD

 Exclusion Criteria:

 -  Women who are pregnant or lactating.

 -  Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma
 are eligible if COPD is currently their primary diagnosis)

 -  Has a respiratory disorder other than COPD (e.g., bronchiectasis, sarcoidosis, active
 tuberculosis, lung fibrosis), including subjects with a diagnosis of
 alpha-1-antitrypsin deficiency.

 -  Subjects with lung volume reduction surgery or lung transplant within the previous 12
 months.

 -  Chest X-ray (posterior-anterior) or CT scan reveals evidence of clinically significant
 abnormalities not believed to be due to the presence of COPD. A chest X-ray must be
 taken if the subject has not had one within 12 months of the Screening Visit.

 -  Subjects with clinically significant cardiovascular (including clinically significant
 ECG abnormalities, CHF), neurological, psychiatric, renal, immunological,
 endocrine(including uncontrolled diabetes or thyroid disease) or hematological
 abnormalities that is uncontrolled.

 -  Subjects with carcinoma that has not been in complete remission for at least 5 years.
 Carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell
 carcinoma would not be considered exclusion criteria if the subject was considered
 cured in less than 5 years since diagnosis.

 -  Any adverse reaction including immediate or delayed hypersensitivity to any
 betaagonist, sympathomimetic drug, or intranasal, inhaled, or oral corticosteroid
 including any components of the formulations (e.g. lactose or milk protein).

 -  Initiation of systemic beta-blocker medications at any time during the study. Systemic
 beta-blockers and beta-blocker eye drops are allowed for those subjects who have been
 on a stable regimen for at least 30 days prior to screening and judged capable to
 continue this regimen until discharged from the study.

 -  Subject continues on any prohibited medications, as listed in Section 5.6.2.

 -  Subject is receiving treatment with long-term oxygen therapy (LTOT), defined as
 inSection 5.6.2.

 -  Use of immunosuppressive medications at any time during the study. Immunotherapy for
 the treatment of allergies is allowed during the study provided that the subject has
 received a constant dose for 30 days prior to the Screening Visit and the dose is
 maintained during the study.

 -  Subjects who are medically unable to withhold their albuterol or ipratropium for the 6
 hour period required prior to administration of questionnaires and spirometry at each
 study visit.

 -  An infection of the upper or lower respiratory tract requiring treatment with
 antibiotics 14 days prior to the Screening Visit.

 -  Subjects who require nocturnal positive pressure.

 -  Enrolled in or discontinuation of a pulmonary rehabilitation program within 30 days of
 Visit 1. Subjects who are enrolled in a pulmonary rehabilitation program at study
 start should maintain participation in the program for the duration of the study.

 -  Use of any investigational drug within 30 days of Visit 1 or at any time during the
 study is not allowed.

 -  Subjects unable to comply with study procedures.

 -  Study investigators, sub-investigators, study coordinators, employees of a
 participating investigator or immediate family members of the aforementioned are
 excluded from participation in this study.

 -  Subjects with a history of psychiatric disease, intellectual deficiency, poor
 motivation, substance abuse, (including drug and alcohol), or other conditions, which
 will limit the validity of informed consent to participate in the study.