ID

41658

Beschreibung

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 (Subject Diary) is to be filled out by study participant between Visit 1 (Screening) and Visit 2 (Randomization), between Visit 2 (Randomization) and Visit 3, between Visit 3 and Visit 4, between Visit 4 and Visit 5 and between Visit 5 and Visit 6. Daily Diary Instructions: Reminders: (for patient) - Bring this Diary and all study medication to each clinic visit. - Do not take any new medications without first contacting the study doctor. - Do not write your name or initials anywhere on this diary. (paper-pen specific) - Withhold albuterol for at least 6 hours prior to your next clinic visit. If you have taken albuterol within 6 hours prior to a visit, contact the clinic to reschedule the visit. - Complete the Medical Problems/Medications Taken Worksheet if you experience any medical problems and take medication(s) for the problem(s). - Withhold your morning dose of blinded study medication prior to the next clinic visit. IF you have taken your morning dose of blinded study medication prior to a visit contact the clinic to reschedule the visit. (NOT applicable for Subject Diary 1) - Record all medical problems which may have occurred on that date, AND all medication(s) you (the subject) took on that date to treat the problem. General rules for Diary completion: - Print neatly using only black or blue ink. Do NOT use pencil. (paper-pen specific) - Draw one line through any changes or mistakes and re-enter the correct information above/beside. (paper-pen specific) - DO NOT use correction fluid or tape. (paper-pen specific) Record the following information in this diary every day. 1. Date. Record dates in DD MMM YY format (for example: 15. OCT 08). 2. Daily Albuterol Use. If you required rescue albuterol for COPD symptoms during the last 24 hour period, record the total number of puffs administered. If none, enter zero (0). 3. Daily Albuterol Nebel Use. If you required rescue albuterol nebulas for COPD symptoms during the last 24 hour period, record the total number of nebulas administered. If none, enter zero (0). 4.1. Morning (AM) Study Medication Taken. Each morning (approximately 6:00-9:00 AM) take 1 inhalation from the SPIRIVA HANDIHALER Device. Record the total number of inhalations of open-blind study medication you took each day from the SPIRIVA HANDIHALER Device. (applicable only for Subject Diary 1) 4.2. Morning (AM) and Evening (PM) Study Medication Taken. Each morning (approximately 6:00-9:00 AM) take 1 inhalation from the DISKUS followed by 1 inhalation from the SPIRIVA HANDIHALER Device. Each evening (approximately 6:00-9:00 PM) approximately 12 hours after the morning dosing with the DISKUS, take 1 inhalation from the DISKUS. Record the total number of inhalations of double-blind study medication you took each day from the DISKUS and the total number of inhalations of open-blind study medication you took each day from the SPIRIVA HANDIHALER Device. (applicable for Subject Diaries 2-5) 5. Medical Problems/Medications Taken Worksheet. Record all medical problems which may have occurred on that date, AND all medication(s) you took on that date to treat the problem on the separate Medical Problems/Medication Taken Worksheet page. Do not include study-related medications.

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Stichworte

Versionen (3)

1. 01.12.20 01.12.20 -
2. 05.12.20 05.12.20 -
3. 05.12.20 05.12.20 -

Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2020

DOI

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