Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03073798
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2017-03-02
Brief Title:
The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Specific Aim To determine the effectiveness of Roflumilast in improving i whole right lung and ii peripheral right lung mucociliary clearance MCC in patients with COPD and chronic bronchitis
Hypothesis Roflumilast increases mucociliary clearance in patients with chronic bronchitis
Study Design This will be a double-blinded cross-over randomized controlled trial with 11 randomization of 20 individuals with chronic bronchitis Subjects will undergo baseline MCC then will be randomized to either roflumilast or placebo x 4 weeks then there will be a 4 week wash-out phase and a second 4 week period of roflumilastplacebo depending on initial randomization MCC will be conducted at baseline and at the end of each 4 week medication phase
Hypothesis Roflumilast increases mucociliary clearance in patients with chronic bronchitis
Study Design This will be a double-blinded cross-over randomized controlled trial with 11 randomization of 20 individuals with chronic bronchitis Subjects will undergo baseline MCC then will be randomized to either roflumilast or placebo x 4 weeks then there will be a 4 week wash-out phase and a second 4 week period of roflumilastplacebo depending on initial randomization MCC will be conducted at baseline and at the end of each 4 week medication phase
Detailed Description:
The purpose of this study is to investigate how well Roflumilast improves mucociliary clearance in people with chronic bronchitis Several studies show that roflumilast may modulate change mucociliary function This study is designed to determine if these favorable effects lead to improved mucociliary clearance MCC in people with chronic bronchitis thereby reducing the potential for acute infections and hospitalizations Daliresp roflumilast is a drug currently marketed approved by the US Food and Drug Administration FDA for use in humans in the US and is indicated used for treatment of people with severe COPD to treat the symptoms of cough and excess mucous linked to chronic bronchitis Roflumilast is used to reduce the risk chance of COPD exacerbations increase in symptoms such as cough mucus secretions and shortness of breath that can be life threatening and reduces the ability to breathe linked to chronic bronchitis swelling of the airways in the lungs Roflumilast is FDA approved to decrease the number of flare-ups of chronic obstructive pulmonary disease COPD in patients with severe COPD with chronic bronchitis and a history of flare-ups The exact way Roflumilast does this is not known Although Roflumilast is an FDA approved drug in this study the drug is not being used for its FDA-approved indication
If you agree to be in this study you will receive no new COPD treatment other than the drugs provided for the study You will also be given a tablet to take once a day which will be placebo for at least part of the study A placebo is a substance that looks like the study drug but that contains no active ingredients
The study is a double-blind study Double-blind means that neither you nor the study doctor will know which study regimen roflumilast or placebo you are receiving throughout the study However this information can be made available if medically necessary and as determined by the participants study You will undergo baseline mucociliary Clearance MCC Measurements then will be randomized by chance like the flip of a coin to receive either roflumilast or placebo for 4 weeks then there will be a 4 week wash-out phase and a second 4 week period of roflumilastplacebo depending on initial randomization Mucociliary Clearance MCC Measurements will be conducted at the beginning and at the end of each 4 week study regimen phase You will be in the study for about 12 weeks and there will be up to 12 visits At baseline and prior to each MCC Procedure you will have health assessments which may include Physical Examination Health and Demographic Interview Exhaled Carbon Monoxide eCO Testing Spirometry Breathing Test Expectorated Sputum Collection Pregnancy Testing and Mucociliary Clearance MCC Measurements
If you agree to be in this study you will receive no new COPD treatment other than the drugs provided for the study You will also be given a tablet to take once a day which will be placebo for at least part of the study A placebo is a substance that looks like the study drug but that contains no active ingredients
The study is a double-blind study Double-blind means that neither you nor the study doctor will know which study regimen roflumilast or placebo you are receiving throughout the study However this information can be made available if medically necessary and as determined by the participants study You will undergo baseline mucociliary Clearance MCC Measurements then will be randomized by chance like the flip of a coin to receive either roflumilast or placebo for 4 weeks then there will be a 4 week wash-out phase and a second 4 week period of roflumilastplacebo depending on initial randomization Mucociliary Clearance MCC Measurements will be conducted at the beginning and at the end of each 4 week study regimen phase You will be in the study for about 12 weeks and there will be up to 12 visits At baseline and prior to each MCC Procedure you will have health assessments which may include Physical Examination Health and Demographic Interview Exhaled Carbon Monoxide eCO Testing Spirometry Breathing Test Expectorated Sputum Collection Pregnancy Testing and Mucociliary Clearance MCC Measurements
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