A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore: (ACROSS)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: Placebo; Drug: Roflumilast; Drug: Salbutamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01313494

RO-2455-301-RD

U1111-1133-6304 (Registry Identifier)

Details and patient eligibility

About

The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.

Enrollment: 626 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Willingness to sign a written informed consent
• Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
• Chinese or Malay or Indian ethnicity
• History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
• Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70%
• Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted
• Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

• Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0
• Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
• History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD
• Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
• Known alpha-1-antitrypsin deficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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626 participants in 2 patient groups, including a placebo group

Roflumilast

Experimental group

Description:

Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.

Treatment:

Drug: Salbutamol

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.

Treatment:

Drug: Salbutamol

Drug: Placebo