Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385463
Status:
WITHDRAWN
Last Update Posted:
2016-06-16
First Post:
2006-10-06
Brief Title:
Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Triple-Dummy Placebo-Controlled Parallel Group Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray Versus Montelukast in AdolescentsAdults With Asthma and Seasonal Allergic Rhinitis Receiving Advair DiskusR or Placebo
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration FDA and are currently available by prescription at your drug store One of the drugs is for the treatment of asthma alone one is for treatment of SAR alone and one is for treatment of both SAR and asthma In addition you will also receive one asthma rescue drug albuterol that is to be used for any breakthrough asthma symptoms that you may experience throughout the study
The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
Detailed Description:
4-week study to assess asthma control as measured by lung function and clinical features rhinitis treatment subject-rated overall satisfaction with treatment and safety outcomes when FLONASE 200mcg FPANS QD Singulair 10mg MON QD or placebo QD is added to ADVAIR DISKUS 10050mcg FSC BID and when Singulair 10mg MON QD is added to placebo DISKUS BID in adolescent and adults subjects Male or female subjects must be symptomatic with both seasonal allergic rhinitis and persistent asthma and have an FEV1 65-95 of predicted while using an as-needed short-acting beta2-agonist or an allowed ICS or non-ICS controller therapy Subjects will replace their short-acting beta2-agonist with VENTOLIN HFA for rescue and will enter a 7-14 day run-in period during which they will continue use of their pre-study controller therapy At Visit 2 subjects who meet both the asthma and rhinitis randomization criteria will be randomized to double-blind treatment with ADVAIR DISKUS 10050mcg BID and either FLONASE 200mcg QD Singulair 10mg QD or placebo QD or to placebo DISKUS BID and Singulair 10mg QD The co-primary efficacy measures will be the mean change from baseline at endpoint in AM PEF compared between the FSC and the MON treatment groups to assess superiority and compared between the FSC and FSCMON treatment groups to assess equivalence Secondary efficacy measures for rhinitis will be mean change from baseline in subject-rated daytime total nasal symptom score and nighttime total nasal symptomatic score averaged over Weeks 1-2 D-TNSSW1-2 and N-TNSSW1-2 respectively Secondary efficacy measures for asthma will be mean change from baseline at endpoint in morning pre-dose FEV1 percentage of symptom-free days and percentage of rescue-free days Other measures will include subject-rated overall satisfaction with treatment evening PEF asthma symptom scores D-INSSW1-x N-INSSW1-2 averaged over Weeks 1-2 Descriptive measures will include all total and individual nasal symptoms scores averaged over Weeks1-4 Safety measures will include assessment of clinical adverse events and asthma exacerbations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None