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

NCT02055352 | Completed Phase 4 Results

• 1 other identifier: CQAB149BAR01
• Study Type: interventional
• Target: 222
• Locations: 8 countries
• Sites: 25

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).

  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.

  Baseline and week 12

Secondary Outcomes (4)

• Change in Health Status - mMRC

  Baseline, week 12 and week 24

• Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment

  24 weeks

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)

  Baseline and week 24

• Change in Health Status - SGRQ-C

  Baseline, week 12 and week 24

Study Arms (2)

Budesonide/indacaterol

EXPERIMENTAL

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.

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

Fluticasone / salmeterol

ACTIVE COMPARATOR

Fixed combination of fluticasone and salmeterol

Drug: Fluticasone; Drug: Salmeterol

Interventions

Budesonide DRUG

Budesonide 400 mcg twice a day via Breezhaler® device

Budesonide/indacaterol

Fluticasone DRUG

Fluticasone 250 mcg twice daily via Accuhaler® device

Budesonide/indacaterol; Fluticasone / salmeterol

Indacaterol DRUG

Indacaterol 150 mcg once daily via Breezhaler® device

Budesonide/indacaterol

Salmeterol DRUG

Salmeterol 50 mcg twice daily via Diskus® device

Budesonide/indacaterol; Fluticasone / salmeterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (25)

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1125ABE, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, C1056ABJ, Argentina

Location

Novartis Investigative Site

Florida, Buenos Aires, B1602DQD, Argentina

Location

Novartis Investigative Site

La Plata, Buenos Aires, 1900, Argentina

Location

Novartis Investigative Site

Vicente López, Buenos Aires, B1638AAI, Argentina

Location

Novartis Investigative Site

Zárate, Buenos Aires, 2800, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, C1425FVH, Argentina

Location

Novartis Investigative Site

Santa Rosa, La Pampa Province, Argentina

Location

Novartis Investigative Site

Salta, Salta Province, 4000, Argentina

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 021941-617, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

Novartis Investigative Site

São Bernardo do Campo, São Paulo, 09750-420, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01244-030, Brazil

Location

Novartis Investigative Site

Rancagua, Rancagua, 2841959, Chile

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 8431633, Chile

Location

Novartis Investigative Site

Santo Domingo, Republica Dominicana, 10205, Dominican Republic

Location

Novartis Investigative Site

Santo Domingo, Republica Dominicana, Dominican Republic

Location

Novartis Investigative Site

Guayaquil, Guayas, 412, Ecuador

Location

Novartis Investigative Site

San Pedro Sula, Honduras, 21102, Honduras

Location

Novartis Investigative Site

Tegucigalpa, Honduras, Honduras

Location

Novartis Investigative Site

León, Guanajuato, 37000, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 03310, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06760, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

Location

Novartis Investigative Site

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Fluticasone; indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 5, 2014
• Study Start: May 30, 2014
• Primary Completion: January 26, 2016
• Study Completion: January 26, 2016
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-04

Locations

ME (4); BR (4); AR (9); DO (2); HO (2); EC (1); CL (2); PA (1)