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

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Budesonide
Drug: Fluticasone
Drug: Indacaterol
Drug: Salmeterol

Registration Number: NCT02055352

Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide/indacaterol	Fluticasone	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.
Budesonide/indacaterol	Budesonide	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.
Budesonide/indacaterol	Indacaterol	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.
Budesonide/indacaterol	Salmeterol	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.
Fluticasone / salmeterol	Fluticasone	Fixed combination of fluticasone and salmeterol
Fluticasone / salmeterol	Salmeterol	Fixed combination of fluticasone and salmeterol

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).	Baseline and week 12	Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

Secondary Outcome Measures

Name	Time	Method
Change in Health Status - mMRC	Baseline, week 12 and week 24	Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment	24 weeks	A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)	Baseline and week 24	Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Change in Health Status - SGRQ-C	Baseline, week 12 and week 24	St George's Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)