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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00411372
Other study ID # SCO105782
Secondary ID
Status Withdrawn
Phase Phase 3
First received December 13, 2006
Last updated February 19, 2015
Start date November 2006

Study information

Verified date February 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary The objective of this study is the validation of the Shortness of Breath Questionnaire in subjects with COPD
Secondary spirometry (FEV1, FVC, IC)
Secondary diary card data
Secondary Health Outcomes (Chronic Respiratory Questionnaire - SAS, Clinical Global Impression of Dyspnea Severity, Patient Global Assessment of Change Question, Clinical Global Impression of Change Question
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