Last updated: 11/04/2018 11:52:59
Shortness Of Breath Questionnaire Validation Study
GSK study ID
SCO105782
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: 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)
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
April 2007 to December 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Inclusion criteria:
- Diagnosis of COPD
Inclusion and exclusion criteria
Inclusion 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.
- 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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