Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

Study Description

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Brief Summary:

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Condition or disease	Intervention/treatment	Phase
COPD; COPD Exacerbation; Lung Diseases; Respiratory Disorders; Pulmonary Disease; Chronic Obstructive Lung Diseases; Chronic Obstructive Airway Disease	Drug: Roflumilast; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2354 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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)
Actual Study Start Date :	September 30, 2011
Actual Primary Completion Date :	November 30, 2015
Actual Study Completion Date :	January 31, 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Roflumilast	Drug: Roflumilast; Roflumilast 500 µg, oral administration, once per day; Other Name: Daliresp
Placebo Comparator: 2; Placebo	Drug: Placebo; Dose-matched placebo, oral administration, once per day.

Outcome Measures

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Primary Outcome Measures :

1. Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. [ Time Frame: Baseline to Week 52 ]
   Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

Secondary Outcome Measures :

1. Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
   Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
2. Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics [ Time Frame: Week 0 (Visit 2) to Week 52 ]
   Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.
3. Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
   Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 1. Male or female patients at least 40 years of age
• 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [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 patients with chronic bronchitis will be included (concomitant emphysema is permitted)
• 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 within 12 months prior to Screening (Visit 1)
• 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
• 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

• 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
• 2. Known alpha-1-antitrypsin deficiency
• 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
• 4. Body mass index (BMI) ≥ 45 kg/m2
• 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 338 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

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Additional Information:

RESPOND Protocol_Redacted 

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01443845 History of Changes
Other Study ID Numbers:	ROF-MD-07
First Posted:	September 30, 2011
Results First Posted:	January 25, 2017
Last Update Posted:	April 13, 2017
Last Verified:	March 2017

Keywords provided by AstraZeneca:

COPD; Exacerbations; Roflumilast; Daliresp

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases