Clinical trial NCT02055352: Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
Official title: 24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-02-05
Enrollment: 222
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in Health Status - mMRC
timeFrame: Baseline, week 12 and week 24
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment
timeFrame: 24 weeks
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)
timeFrame: Baseline and week 24
measure: Change in Health Status - SGRQ-C
timeFrame: Baseline, week 12 and week 24
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Florida
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Zarate
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Novartis Investigative Site
state: La Pampa
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Sao Bernardo do Campo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Santiago
country: Chile
facility: Novartis Investigative Site
state: Region Metropolitana
city: Rancagua
country: Chile
facility: Novartis Investigative Site
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Guayaquil
country: Ecuador
facility: Novartis Investigative Site
state: Guayas
city: San Pedro Sula
country: Honduras
facility: Novartis Investigative Site
city: Tegucigalpa
country: Honduras
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: León
country: Mexico
facility: Novartis Investigative Site
state: Guanajuato
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: