Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— INSIST  

Official title:

A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821093
• Other study ID #: CQAB149B2349
• Secondary ID: 2008-005146-23
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: July 22, 2011
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ministry of HealthIndia: Drugs Controller General of IndiaGermany: Ethics CommissionSpain: Spanish Agency of MedicinesSlovakia: State Institute for Drug ControlHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1123
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Adults aged = 40 years

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) and:

• Smoking history of at least 10 pack years

• Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and = 30% of the predicted normal value at screening

• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% at screening

Exclusion Criteria:

• Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period

• Patients requiring long-term oxygen therapy (> 15 h a day) for chronic hypoxemia

• Patients who have had a respiratory tract infection within 6 weeks prior to screening

• Patients with concomitant pulmonary disease

• Patients with a history of asthma

• Patients with diabetes Type I or uncontrolled diabetes Type II

• Any patient with lung cancer or a history of lung cancer

• Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time

• Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged

• Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period

• Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

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 150 µg
Indacaterol 150 µg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
• Salmeterol 50 µg
Salmeterol 50 µg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
• Placebo to indacaterol
Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
• Placebo to salmeterol
Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).

Locations

Country	Name	City	State
Czech Republic	Novartis Investigator Site	Cvikov
Czech Republic	Novartis Investigator Site	Kyjov
Czech Republic	Novartis Investigator Site	Lovosice
Czech Republic	Novartis Investigator Site	Neratovice
Czech Republic	Novartis Investigator Site	Ostrava
Czech Republic	Novartis Investigator Site	Pardubice
Czech Republic	Novartis Investigator Site	Prague
Czech Republic	Novartis Investigator Site	Teplice
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Backnang
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Borstel
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigator Site	Frankfurt
Germany	Novartis Investigative Site	Geesthacht
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigator Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Neumuenster
Germany	Novartis Investigative SIte	Oschersleben
Germany	Novartis Investigative Site	Ruedersdorf
Germany	Novartis Investigative Site	Weyhe
Germany	Novartis Investigative Site	Wiesloch
Germany	Novartis Investgative Site	Witten
Hungary	Novartis Investigator Site	Budapest
Hungary	Novartis Investigator Site	Debrecen
Hungary	Novartis Investigative Site	Deszk
Hungary	Novartis Investigator Site	Mosonmagyarovar
Hungary	Novartis Investigator Site	Nyiregyhaza
Hungary	Novartis Investigator Site	Tatabanya
Hungary	Novartis Investigator Site	Torokbalint
India	Novartis Investigator Site	Chennai
India	Novartis Investigator Site	Hyderabad
India	Novartis Investigator Site	Jaipur
India	Novartis Investigator Site	Mangalore
India	Novartis Investigator Site	Panjim
India	Novartis Investigator Site	Pune
India	Novartis Investigator Site	Trivandrum
India	Novartis Investigator Site	Vellore
Slovakia	Novartis Investigative Site	Bojnice
Slovakia	Novartis Investigator Site	Bratislava
Slovakia	Novartis Investigative Site	Humenne
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigator Site	Liptovsky Hradok
Slovakia	Novartis Investigative Site	Partizanske
Slovakia	Novartis Investigative Site	Spisska Nova Ves
Spain	Novartis Investigator Site	Alicante
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Caceres
Spain	Novartis Investigative Site	Cordoba
Spain	Novartis Investigative Site	La Coruna
Spain	Novartis Investigative Site	Merida
Spain	Novartis Investigative Site	Orense
Spain	Novartis Investigative Site	Valencia
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigator Site	Istanbul
Turkey	Novartis Investigator Site	Izmir
Turkey	Novartis Investigator Site	Kartal/Istanbul
Turkey	Novartis Investigative Site	Kinikli / Denizli
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigator Site	Yenisehir/Izmir
United States	Novartis Investigative Site	Abingdon	Virginia
United States	Novartis Investigator Site	Albuquerque	New Mexico
United States	Novartis Investigator Site	Ann Arbor	Michigan
United States	Novartis Investigator Site	Anniston	Alabama
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigator Site	Buena Park	California
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cherry Hill	New Jersey
United States	Novartis Investigator Site	Cincinnati	Ohio
United States	Novartis Investigative Center	Clearwater	Florida
United States	Novartis Investigator Site	Columbus	Ohio
United States	Novartis Investigator Site	El Paso	Texas
United States	Novartis Investigator Site	Encinitas	California
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigator Site	Eugene	Oregon
United States	Novartis Investigator Site	Fairhope	Alabama
United States	Novartis Investigator Site	Fort Collins	Colorado
United States	Novartis Investigator Site	Fort Worth	Texas
United States	Novartis Investigator Site	Fullerton	California
United States	Novartis Investigator Site	Glendale	Arizona
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigator Site	Henderson	Nevada
United States	Novartis Investigative Site	Hickory	North Carolina
United States	Novartis Investigator Site	Houston	Texas
United States	Novartis Investigator Site	Jasper	Alabama
United States	Novartis Investigative Site	Larchmont	New York
United States	Novartis Investigator Site	Lincoln	Nebraska
United States	Novartis Investigator Site	Livonia	Michigan
United States	Novartis Investigator Site	Madisonville	Kentucky
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigator Site	Medford	Oregon
United States	Novartis Investigator Site	Milwaukee	Wisconsin
United States	Novartis Investigator Site	Minneapolis	Minnesota
United States	Novartis Investigator Site	Mobile	Alabama
United States	Novartis Investigator Site	New Orleans	Louisiana
United States	Novartis Investigative Site	Newark	Delaware
United States	Novartis Investigator Site	Normal	Illinois
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigator Site	Olathe	Kansas
United States	Novartis Investigator Site	Omaha	Nebraska
United States	Novartis Investigator Site	Opelousas	Louisiana
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigator Site	Phoenix	Arizona
United States	Novartis Investigator Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigator Site	Rancho Mirage	California
United States	Novartis Investigative Site	Reno	Nevada
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigator Site	River Forest	Illinois
United States	Novartis Investigator Site	Riverside	California
United States	Novartis Investigator Site	San Antonio	Texas
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigator Site	Skokie	Illinois
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative site	Spartanburg	South Carolina
United States	Novartis Investigator Site	Spokane	Washington
United States	Novartis Investigator Site	St Charles	Missouri
United States	Novartis Investigator Site	St Louis	Missouri
United States	Novartis Investigative Site	Stamford	Connecticut
United States	Novartis Investigative Site	Summit	New Jersey
United States	Novartis Investigator Site	Tacoma	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigator Site	Torrance	California
United States	Novartis Investigator Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Union	South Carolina
United States	Novartis Investigator Site	Walnut Creek	California
United States	Novartis Investigative Site	Wheat Ridge	Colorado
United States	Novartis Investigator Site	Wichita	Kansas
United States	Novartis Investigator Site	Willoughby Hills	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany,  Hungary,  India,  Slovakia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.	From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.	24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)	No