A 52-WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFECT OF ROFLUMILAST 500 μg ON EXACERBATION RATE IN SUBJECTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATED WITH A FIXED-DOSE COMBINATION OF LONG-ACTING BETA AGONIST AND INHALED CORTICOSTEROID (LABA/ICS)

Not Applicable

• Registration Number: PER-114-11
• Lead Sponsor: Forest Research Institute, Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 71

Inclusion Criteria

1. MALE OR FEMALE SUBJECTS AT LEAST 40 YEARS OF AGE.
2. HISTORY OF COPD (ACCORDING TO GOLD 2010) FOR AT LEAST 12 MONTHS PRIOR TO SCREENING (VISIT 1) ASSOCIATED WITH CHRONIC PRODUCTIVE COUGH FOR 3 MONTHS IN EACH OF 2 CONSECUTIVE YEARS (WITH OTHER CAUSES OF PRODUCTIVE COUGH EXCLUDED). ONLY SUBJECTS WITH CHRONIC BRONCHITIS WILL BE INCLUDED.
3. FORCED EXPIRATORY VOLUME AFTER 1 SECOND (FEV₁)/FORCED VITAL CAPACITY (FVC) RATIO (POSTBRONCHODILATOR) < 70% AT SCREENING (VISIT 1).
4. FEV₁ (POSTBRONCHODILATOR) ≤ 50% OF PREDICTED AT SCREENING (VISIT 1).
5. AT LEAST TWO DOCUMENTED MODERATE OR SEVERE COPD EXACERBATIONS WIHTIN 12 MONTHS PRIOR TO SCREENING (VISIT 1).
6. SUBJECTS MUST BE ON FDC LABA/ICS (ADVAIR® 250/50 μg 1 puff BID OR, SYMBICORT® 160/4,5 μg 2 puffs BID) CONCOMITANT TREATMENT ≥ 3 MONTHS PRIOR TO SCREENING (VISIT 1).
7. THSE SUBJECTS WHO WERE PREVIOUSLY TREATED WITH LAMA MUST HAVE BEEN ON A STABLE DOSE FOR ≥ 3 MONTHS BEFORE SCREENING (VISIT 1) AND MUST CONTINUE ON THE SAME DOSE THROUGHOUT THE STUDY.
8. FORMER SMOKER (DEFINED AS SMOKING CESSATION AT LEAST 1 YEAR AGO) OR CURRENT SMOKER BOTH WITH A SMOKING HISTORY OF AT LEAST 20 PACK-YEARS.

Exclusion Criteria

1. SEVERE OR VERY SEVERE COPD EXACERBATION AND/OR COPD EXACERBATIONS TREATED WITH ANTIBIOTICS OR SYSTEMIC GLUCOCORTICOSTEROIDS WITHIN 4 WEEKS OF SCREENING (VISIT 1) (ie, SUBJECTS MUST BE CLINICALLY STABLE).
2. LOWER RESPIRATORY TRACT INFECTION WITHIN 4 WEEKS OF SCREENING (VISIT 1).
3. DIAGNOSIS OF SIGNIFICANT LUNG DISEASE OTHER THAN COPD (eg., HISTORY OF PRIMARY BRONCHIECSTASIS, CYSTIC FIBROSIS, BRONCHIOLITIS, LUNG RESECTION, LUNG CANCER, INTERSTITIAL LUNG DISEASE [eg., FIBROSIS, SILICOSIS, SARCOIDOSIS], OR ACTIVE TUBERCULOSIS, PULMONARY THROMBOEMBOLIC DISEASE), PULMONARY RESECTION OR LUNG VOLUME SURGERY DURING THE PAST 12 MONTHS, CYSTIC FIBROSIS, KARTAGENER SYNDROME) POST ORGAN TRANSPLANTATION, OR WHO ARE EXPECTED TO REQUIRE THORACOTOMY OR OTHER LUNG SURGERY DURING THE STUDY.
4. KNOWN ALFA-1-ANTITRYPSIN DEFICIENCY.
5. CURRENT DIAGNOSIS OF ASTHMA (EITHER CONTROLLED OR UNCONTROLLED).
6. LIVER IMPAIRMENT CHILD-PUGH B OR C AND/OR ACTIVE VIRAL HEPATITIS.
7. CHRONIC USE OF OXYGEN THERAPY ≥ 15 hours/day
8. BODY MASS INDEX (BMI) ≥ 45 kg/m²

Study & Design

• Study Type: Interventional
• Study Design: Not specified