QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ILLUMINATE  

Official title:

A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315249
• Other study ID #: CQVA149A2313
• Secondary ID: 2010-023621-37
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2011
• Last updated: July 9, 2013
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineHungary: National Institute of PharmacyGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and ResearchGermany: Federal Ministry of Food, Agriculture and Consumer ProtectionGermany: German Institute of Medical Documentation and InformationGermany: Ministry of HealthGermany: Paul-Ehrlich-InstitutKorea: Food and Drug AdministrationLithuania: Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of HealthSouth Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Norwegian Institute of Public HealthNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research EthicsSpain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Smoking history of at least 10 pack years

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)

• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Exclusion Criteria:

• Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.

• Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

• Patients with concomitant pulmonary disease

• Patients with a history of asthma

• Any patient with lung cancer or a history of lung cancer (within last 5 years)

• Patients with a history of certain cardiovascular co-morbid conditions

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• indacaterol and glycopyrronium (QVA149)
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
• Placebo to fluticasone/salmeterol
Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
• fluticasone/salmeterol
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
• Placebo to indacaterol and glycopyrronium (QVA149)
Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Jambes
Belgium	Novartis Investigative Site	Jette
Belgium	Novartis Investigative Site	Luxembourg
Belgium	Novartis Investigative Site	Malmedy
Czech Republic	Novartis Investigative Site	Cvikov
Czech Republic	Novartis Investigative Site	JIndrichuv Hradec
Czech Republic	Novartis Investigative Site	Kyjov	CZE
Czech Republic	Novartis Investigative Site	Melnik
Czech Republic	Novartis Investigative Site	Pardubice
Czech Republic	Novartis Investigative Site	Prague 3
Czech Republic	Novartis Investigative Site	Praha 10
Czech Republic	Novartis Investigative Site	Teplice
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Bad Woerishofen
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Borstel
Germany	Novartis Investigative Site	Dueren
Germany	Novartis Investigative Site	Eschwege
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freudenberg
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Fürstenwalde/Spree
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Gummersbach
Germany	Novartis Investigative Site	Güstrow
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Oschersleben
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Saarbrücken
Germany	Novartis Investigative Site	Schwerte
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wissen
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Cegled
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Eger
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Mosonmagyarovar
Hungary	Novartis Investigative Site	Szarvas
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Torokbalint
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon
Lithuania	Novartis Investigative Site	Alytus
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Utena
Lithuania	Novartis Investigative Site	Vilnius
Norway	Novartis Investigative Site	Ålesund
Norway	Novartis Investigative Site	Kongsvinger
Norway	Novartis Investigative Site	Skedsmokorset
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Trondheim
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Sabadell	Cataluña
Spain	Novartis Investigative Site	Sant Boi de Llobregat	Cataluña
Spain	Novartis Investigative Site	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Estonia,  Germany,  Hungary,  Korea, Republic of,  Lithuania,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12	Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.	Week 26	No
Secondary	Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours	Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.	Week 12	No
Secondary	Forced Vital Capacity at All-time Points (Week 12)	Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.; This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.	-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12	No
Secondary	Forced Vital Capacity at All-time Points (Week 26)	Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.; This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.	-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26	No
Secondary	Focal Score of the Transitional Dyspnea Index (TDI)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.	12 weeks and 26 weeks	No
Secondary	Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)	The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.	12 weeks and 26 weeks	No
Secondary	Mean Change From Baseline in Daily Number of Puffs of Rescue Medication	Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.	Baseline, 12 weeks and 26 weeks	No
Secondary	Change From Baseline in Symptom Scores Reported Using the Ediary	Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.; Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.; 0 is the minimum score = "none" or "No symptoms" or "never" or "No"; = mild, a little; = moderate; = severe For the scale range provided, high values represent a worse outcome.	12 weeks and 26 weeks	No
Secondary	Inspiratory Capacity (IC) at All-time Points (12 Weeks)	After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.	12 weeks	No
Secondary	Inspiratory Capacity (IC) at All-time Points (26 Weeks)	After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.	26 weeks	No
Secondary	Number of Participants With Adverse Events	The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.	26 weeks	Yes