Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD (COMBINE)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Fluticasone; Drug: Indacaterol; Drug: Salmeterol; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02055352

CQAB149BAR01

Details and patient eligibility

About

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Enrollment: 222 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed
• Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines.
• Current or ex-smokers who have a smoking history of at least 10 pack years
• Patients with a history of at least one exacerbation.
• Patients able to read and complete

Exclusion criteria

• Use of other investigational drugs within 30 days
• Patients with a history of hypersensitivity to any of the study drugs
• History or current diagnosis of ECG abnormalities
• Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range
• Patients who have not achieved an acceptable spirometry result at Visit 1
• Patients with a body mass index (BMI) of more than 40 kg/m2
• Patients with lung cancer or a history of lung cancer
• Patients with a history of malignancy of any organ system
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
• Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers)
• Patients that are uncontrolled or unstable on permitted therapy, who in the opinion of the investigator, have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
• Patients requiring oxygen therapy for chronic hypoxemia
• Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
• Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension
• Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency.
• Patients with history of lung surgery
• Patients who are participating in the active phase of a supervised pulmonary rehabilitation program.
• Patients with a history of asthma Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Budesonide/indacaterol

Experimental group

Description:

Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.

Treatment:

Drug: Salmeterol

Drug: Fluticasone

Drug: Indacaterol

Drug: Budesonide

Fluticasone / salmeterol

Active Comparator group

Description:

Fixed combination of fluticasone and salmeterol

Treatment:

Drug: Salmeterol

Drug: Fluticasone