- 11/11/20 - 1 form, 4 itemgroups, 41 items, 1 language
Itemgroups: Administrative Data, Chest X-ray, Cultures and clinical findings, Treatment and Outcome
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.
- 1/8/19 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative data, X Ray Pneumonia Confirmation (X-ray)
- 11/17/18 - 1 form, 9 itemgroups, 81 items, 1 language
Itemgroups: Concomitant Medication, Asthma Exacerbations, Contact Method/ Treatment site for ExacerbationsMethod, Exacerbation Medications, IP Device Malfunction, Chest X-Ray, Pharmacogenetic (PGx) Research Consent/ Sample Collection, Investigational Product Compliance, Unscheduled Asthma related Healthcare Resource Utilisation
- 8/6/15 - 5 forms, 22 itemgroups, 81 items, 1 language
Itemgroups: EXCEPTION, PREVIOUS AND CURRENT MEDICATIONS, PRE-TREATMENT EVENTS, BONE MARROW BIOPSY/ ASPIRATE, ELECTROCARDIOGRAM, CHEST X-RAY, TRANSFUSIONS, FLUORESCENT IN SITU HYBRIDIZATION, EXTERNAL DATA TRACKING, LABORATORY TEST RESULTS, DRUG DISPENSATION, BMS-354825 DOSING, CONCOMITANT MEDICATIONS, NON-SERIOUS ADVERSE EVENTS, DEATH DATA, ENROLLMENT IN PREVIOUS BMS CA180 PROTOCOL, DOSE ADMINISTRATION FOR UNSCHEDULED CSF, CSF PHARMACOKINETICS, BLOOD PHARMACOKINETICS, DOSE ADMINISTRATION, PLEURAL OR OTHER BODY FLUID PHARMACOKINETICS, DIAGNOSTIC PROCEDURES

Serious Adverse Event (SAE)- Form

3 itemgroups 36 items

Pharmacokinetics

4 itemgroups 22 items

Follow- Up

3 itemgroups 11 items

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