Phase 4 N=12 Randomized Quadruple-blind Treatment

The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis

COPD · Chronic Bronchitis · Emphysema

Bottom Line

View on ClinicalTrials.gov: NCT03073798 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Jul 2017

Primary outcome: Primary: Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A — -1.50; -0.70 percentage difference of MCC

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Roflumilast (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-1.31; 0.52	—
PRIMARY Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-1.31; 0.52	—
PRIMARY Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A	-1.31; 0.52	—
PRIMARY Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B	-0.13; 6.93	—

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 1:1 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 roflumilast/placebo depending on initial randomization. MCC will be conducted at baseline and at the end of each 4 week medication phase.

Eligibility Criteria

Inclusion Criteria

Physician diagnosis of COPD
Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) ≤70%
FEV1 (% predicted) ≥40 % AND ≤ 70%,
Tobacco exposure ≥ 10 pack-years,
Chronic cough and sputum production
At least one COPD exacerbation requiring systemic glucocorticosteroids or treatment in hospital, or both, in the previous year
Not suffering from any concomitant disease that might interfere with study procedures or evaluations.

Exclusion Criteria

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit V0
Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis
Known alpha-1-antitrypsin deficiency
Known infection with HIV and/or active hepatitis
Pregnancy or women of childbearing potential not using or willing to continue using a medically reliable method of contraception for the entire study period
Suspected hypersensitivity to the study medication (roflumilast).
Use of mucolytics within the last 4 weeks.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03073798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.