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

Chronic Obstructive Pulmonary Disease Clinical Trial

— COMBINE  

Official title:

24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055352
• Other study ID #: CQAB149BAR01
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: April 17, 2017
• Start date: May 30, 2014
• Est. completion date: January 26, 2016

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: January 26, 2016
• Est. primary completion date: January 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide
Budesonide 400 mcg twice a day via Breezhaler® device
• Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
• Indacaterol
Indacaterol 150 mcg once daily via Breezhaler® device
• Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As
Argentina	Novartis Investigative Site	Florida	Buenos Aires
Argentina	Novartis Investigative Site	La Plata	Buenos Aires
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	Santa Rosa	La Pampa
Argentina	Novartis Investigative Site	Vicente Lopez	Buenos Aires
Argentina	Novartis Investigative Site	Zarate	Buenos Aires
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Bernardo do Campo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Chile	Novartis Investigative Site	Rancagua
Chile	Novartis Investigative Site	Santiago	Region Metropolitana
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Ecuador	Novartis Investigative Site	Guayaquil	Guayas
Honduras	Novartis Investigative Site	San Pedro Sula
Honduras	Novartis Investigative Site	Tegucigalpa
Mexico	Novartis Investigative Site	León	Guanajuato
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Panama	Novartis Investigative Site	Panama City	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Dominican Republic,  Ecuador,  Honduras,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Health Status - mMRC	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	Baseline, week 12 and week 24
Secondary	Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment	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.	24 weeks
Secondary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)	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.	Baseline and week 24
Secondary	Change in Health Status - SGRQ-C	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)	Baseline, week 12 and week 24