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

NCT ID: NCT00821093

Last Updated: 2011-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol 150 µg

Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol 150 µg

Intervention Type DRUG

Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Salmeterol 50 µg

Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type ACTIVE_COMPARATOR

Salmeterol 50 µg

Intervention Type DRUG

Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Interventions

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Indacaterol 150 µg

Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Intervention Type DRUG

Salmeterol 50 µg

Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Intervention Type DRUG

Placebo to indacaterol

Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Intervention Type DRUG

Placebo to salmeterol

Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Anniston, Alabama, United States

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Fairhope, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Buena Park, California, United States

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Encinitas, California, United States

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Fullerton, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Fort Collins, Colorado, United States

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Wheat Ridge, Colorado, United States

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Stamford, Connecticut, United States

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Newark, Delaware, United States

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Novartis Investigative Center

Clearwater, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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South Miami, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Marietta, Georgia, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Skokie, Illinois, United States

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Olathe, Kansas, United States

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Wichita, Kansas, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Opelousas, Louisiana, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Livonia, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Reno, Nevada, United States

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Cherry Hill, New Jersey, United States

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Summit, New Jersey, United States

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Albuquerque, New Mexico, United States

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Larchmont, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Shelby, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Willoughby Hills, Ohio, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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North Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Cvikov, , Czechia

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Kyjov, , Czechia

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Lovosice, , Czechia

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Neratovice, , Czechia

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Ostrava, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Backnang, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Borstel, , Germany

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Dortmund, , Germany

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Duisburg, , Germany

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Frankfurt, , Germany

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Geesthacht, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Karlsruhe, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Neumünster, , Germany

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Oschersleben, , Germany

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Rüdersdorf, , Germany

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Weyhe, , Germany

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Wiesloch, , Germany

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Witten, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Mosonmagyaróvár, , Hungary

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Nyíregyháza, , Hungary

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Tatabánya, , Hungary

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Törökbálint, , Hungary

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Chennai, , India

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Hyderabad, , India

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Jaipur, , India

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Mangalore, , India

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Panjim, , India

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Pune, , India

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Trivandrum, , India

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Vellore, , India

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Humenné, , Slovakia

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Košice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Partizánske, , Slovakia

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Spišská Nová Ves, , Slovakia

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A Coruña, , Spain

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Alicante, , Spain

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Barcelona, , Spain

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Cáceres, , Spain

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Córdoba, , Spain

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Mérida, , Spain

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Ourense, , Spain

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Valencia, , Spain

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Altunizade, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kartal/Istanbul, , Turkey (Türkiye)

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Kinikli / Denizli, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Countries

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United States Czechia Germany Hungary India Slovakia Spain Turkey (Türkiye)

References

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Korn S, Kerwin E, Atis S, Amos C, Owen R, Lassen C; INSIST study group. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. Respir Med. 2011 May;105(5):719-26. doi: 10.1016/j.rmed.2011.02.008. Epub 2011 Mar 1.

Reference Type DERIVED
PMID: 21367594 (View on PubMed)

Other Identifiers

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2008-005146-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAB149B2349

Identifier Type: -

Identifier Source: org_study_id

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