Shortness Of Breath Questionnaire Validation Study

A Randomized, Double-blind, Parallel-group Study of Fluticasone Propionate/Salmeterol Combination (FSC 250/50mcg) Twice Daily and Salmeterol (SAL 50mcg) Twice Daily to Validate a New Shortness of Breath Questionnaire in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00411372

Enrollment

Registered

2006-12-14

Start date

2006-11-30

Completion date

Unknown

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Questionnaire, COPD, Shortness of Breath

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

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The objective of this study is the validation of the Shortness of Breath Questionnaire in subjects with COPD	—

Secondary

Measure	Time frame
spirometry (FEV1, FVC, IC)	—
diary card data	—
Health Outcomes (Chronic Respiratory Questionnaire - SAS, Clinical Global Impression of Dyspnea Severity, Patient Global Assessment of Change Question, Clinical Global Impression of Change Question	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026