Shortness Of Breath Questionnaire Validation Study

NCT ID: NCT00411372

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

fluticasone propionate/salmeterol 250/50mcg combination, salmeterol 50mcg

Intervention Type: DRUG

Other Intervention Names

fluticasone propionate/salmeterol 250/50mcg combination; salmeterol 50mcg

Eligibility Criteria

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.
• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

SCO105782

Identifier Type: -

Identifier Source: org_study_id