A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

NCT00900731 | Completed Phase 3 Results

• 1 other identifier: CQAB149B2350
• Study Type: interventional
• Target: 1,598
• Locations: 22 countries
• Sites: 212

Brief Summary

This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; indacaterol; beta 2 agonist; tiotropium

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)

  Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.

  End of treatment (Week 12)

Secondary Outcomes (7)

• Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)

  5 minutes to 4 hours post-dose at the end of treatment (week 12)

• Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment

  12 weeks

• Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment

  12 weeks

• Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)

  Baseline, up to 12 weeks

• Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)

  Baseline, up to 12 weeks

Study Arms (2)

Indacaterol 150 µg

EXPERIMENTAL

Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.

Drug: Indacaterol 150 μg; Drug: Placebo to tiotropium

Tiotropium 18 µg

ACTIVE COMPARATOR

Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.

Drug: Tiotropium 18 μg; Drug: Placebo to indacaterol

Interventions

Indacaterol 150 μg DRUG

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

Indacaterol 150 µg

Tiotropium 18 μg DRUG

Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Tiotropium 18 µg

Placebo to indacaterol DRUG

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

Tiotropium 18 µg

Placebo to tiotropium DRUG

Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Indacaterol 150 µg

Eligibility Criteria

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

You may qualify if:

• \- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
• a) Smoking history of at least 10 pack-years
• b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
• c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

You may not qualify if:

• Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
• 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
• Patients with a history of certain cardiovascular comorbid conditions

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (212)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

Location

Novartis Investigator Site

Jasper, Alabama, 35501, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85050, United States

Location

Novartis Investigative Site

Tucson, Arizona, 85723, United States

Location

Novartis Investigator Site

Anaheim, California, 92801, United States

Location

Novartis Investigator Site

Stockton, California, 95207, United States

Location

Novartis Investigator Site

Walnut Creek, California, 94598, United States

Location

Novartis Investigator Site

Fort Collins, Colorado, 80528, United States

Location

Novartis Investigator Site

Wheat Ridge, Colorado, 80033, United States

Location

Novartis Investigative Site

South Miami, Florida, 33143, United States

Location

Novartis Investigator Site

Normal, Illinois, 61761, United States

Location

Novartis Investigative Site

Evansville, Indiana, 47710, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Lafayette, Louisiana, 70503, United States

Location

Novartis Investigative Center

Saint Charles, Missouri, 63301, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68510, United States

Location

Novartis Investigative Site

Henderson, Nevada, 89014, United States

Location

Novartis Investigative Site

Albany, New York, 12205, United States

Location

Novartis Investigative Site

Larchmont, New York, 10538, United States

Location

Novartis Investigative Site

New York, New York, 10016, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43214, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23229, United States

Location

Novartis Investigator Site

Feldbach, Austria

Location

Novartis Investigator Site

Gänserndorf, Austria

Location

Novartis Investigator Site

Hallein, Austria

Location

Novartis Investigator Site

Brussels, Belgium

Location

Novartis Investigator Site

Gilly, Belgium

Location

Novartis Investigator Site

Jambes, Belgium

Location

Novartis Investigator Site

Jette, Belgium

Location

Novartis Investigator Site

Liège, Belgium

Location

Novartis Investigator Site

Montigny-le-Tilleul, Belgium

Location

Novartis Investigator Site

Ostend, Belgium

Location

Novartis Investigator Site

Sankt Vith, Belgium

Location

Novartis Investigator Site

Yvoir, Belgium

Location

Novartis Investigator Site

Calgary, Canada

Location

Novartis Investigative Site

Greater Sudbury, Canada

Location

Novartis Investigative Site

Mississauga, Canada

Location

Novartis Investigative Site

Moncton, Canada

Location

Novartis Investigative Site

New Market, Canada

Location

Novartis Investigative SIte

Québec, Canada

Location

Novartis Investigative Site

Saint Romuald, Canada

Location

Novartis Investigator Site

Barranquilla, Colombia

Location

Novartis Investigator Site

Bogotá, Colombia

Location

Novartis Investigator Site

Medellín, Colombia

Location

Novartis Investigator Site

Aalborg, Denmark

Location

Novartis Investigator Site

Frederiksberg, Denmark

Location

Novartis Investigator Site

Næstved, Denmark

Location

Novartis Investigator Site

Roskilde, Denmark

Location

Novartis Investigator Site

Sønderborg, Denmark

Location

Novartis Investigator Site

Viborg, Denmark

Location

Novartis Investigator Site

Værløse, Denmark

Location

Novartis Investigator Site

Helsinki, Finland

Location

Novartis Investigator Site

Jyväskylä, Finland

Location

Novartis Investigator Site

Lahti, Finland

Location

Novartis Investigator Site

OYS, Finland

Location

Novartis Investigator Site

Pori, Finland

Location

Novartis Investigator Site

Turku, Finland

Location

Novartis Investigative Site

Ambroise, France

Location

Novartis Investigative Site

Antibes, France

Location

Novartis Investigator Site

Beuvry, France

Location

Novartis Investigator Site

Ferolles-Attily, France

Location

Novartis Investigative Site

Montpellier, France

Location

Novartis Investigator Site

Nantes, France

Location

Novartis Investigative Site

Nice, France

Location

Novartis Investigative Site

Nîmes, France

Location

Novartis Investigative Site

Paris, France

Location

Novartis Investigator Site

Paris, France

Location

Novartis Investigative Site

Pessac, France

Location

Novartis Investigator Site

Pierre-Bénite, France

Location

Novartis Investigative Site

Suresnes, France

Location

Novartis Investigator Site

Vandoeuvre Les Nancys, France

Location

Novartis Investigator Site

Bergisch Gladbach, Germany

Location

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Bochum, Germany

Location

Novartis Investigator Site

Bonn, Germany

Location

Novartis Investigator Site

Buchholz, Germany

Location

Novartis Investigator Site

Coburg, Germany

Location

Novartis Investigator Site

Düren, Germany

Location

Novartis Investigator Site

Eggenfelden, Germany

Location

Novartis Investigator Site

Eschwege, Germany

Location

Novartis Investigator Site

Euskirchen, Germany

Location

Novartis Investigator Site

Freudenberg, Germany

Location

Novartis Investigator Site

Fürth, Germany

Location

Novartis Investigator Site

Gelsenkirchen, Germany

Location

Novartis Investigator Site

Gummersbach, Germany

Location

Novartis Investigator Site

Hagen, Germany

Location

Novartis Investigator Site

Halle, Germany

Location

Novartis Investigator Site

Hamburg, Germany

Location

Novartis Investigator Site

Hanover, Germany

Location

Novartis Investigator Site

Hoyerswerda, Germany

Location

Novartis Investigator Site

Kassel, Germany

Location

Novartis Investigative Site

Landsberg, Germany

Location

Novartis Investigator Site

Leipzig, Germany

Location

Novartis Investigator Site

Mainz, Germany

Location

Novartis Investigator Site

Munich, Germany

Location

Novartis Investigator Site

Oranienburg, Germany

Location

Novartis Investigator Site

Radebeul, Germany

Location

Novartis Investigator Site

Ratingen, Germany

Location

Novartis Investigator Site

Ruhmannsfelden, Germany

Location

Novartis Investigator Site

Rüsselsheim am Main, Germany

Location

Novartis Investigator Site

Solingen, Germany

Location

Novartis Investigator Site

Stockach, Germany

Location

Novartis Investigator Site

Teterow, Germany

Location

Novartis Investigator Site

Vilshofen, Germany

Location

Novartis Investigator Site

Wallerfing, Germany

Location

Novartis Investigator Site

Wissen, Germany

Location

Novartis Investigator Site

Athens, Greece

Location

Novartis Investigative Site

Budapest, Hungary

Location

Novartis Investigator Site

Budapest, Hungary

Location

Novartis Investigator Site

Debrecen, Hungary

Location

Novartis Investigative Site

Farkasgyepű, Hungary

Location

Novartis Investigative Site

Gödöllő, Hungary

Location

Novartis Investigator Site

Szolnok, Hungary

Location

Novartis Investigator Site

Haifa, Israel

Location

Novartis Investigator Site

Petah Tikva, Israel

Location

Novartis Investigator Site

Ancona, Italy

Location

Novartis Investigator Site

Foggia, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigator Site

Milan, Italy

Location

Novartis Investigative Site

Pavia, Italy

Location

Novartis Investigator Site

Pavia, Italy

Location

Novartis Investigative Site

Pisa, Italy

Location

Novartis Investigator Site

Pisa, Italy

Location

Novartis Investigative Site

Huxquilucan, Mexico

Location

Novartis Investigator Site

Mexico City, Mexico

Location

Novartis Investigative Site

San Luis Potosí City, Mexico

Location

Novartis Investigative Site

Ålesund, Norway

Location

Novartis Investigator Site

Ålesund, Norway

Location

Novartis Investigator Site

Drammen, Norway

Location

Novartis Investigator Site

Follebu, Norway

Location

Novartis Investigative Site

Kongsberg, Norway

Location

Novartis Investigator Site

Kongsberg, Norway

Location

Novartis Investigator Site

Kongsvinger, Norway

Location

Novartis Investigator Site

Lierskogen, Norway

Location

Novartis Investigative Site

Oslo, Norway

Location

Novartis Investigator Site

Oslo, Norway

Location

Novartis Investigator Site

Sandvika, Norway

Location

Novartis Investigative Site

Skedsmokorset, Norway

Location

Novartis Investigator Site

Stavanger, Norway

Location

Novartis Investigative Site

Trondheim, Norway

Location

Novartis Investigator Site

Trondheim, Norway

Location

Novartis Investigator Site

Gdansk, Poland

Location

Novartis Investigator Site

Katowice, Poland

Location

Novartis Investigative Site

Krakow, Poland

Location

Novartis Investigator Site

Krakow, Poland

Location

Novartis Investigator Site

Piekary Śląskie, Poland

Location

Novartis Investigator Site

Warsaw, Poland

Location

Novartis Investigator Site

Wroclaw, Poland

Location

Novartis Investigator Site

Barnaul, Russia

Location

Novartis Investigator Site

Kazan', Russia

Location

Novartis Investigator Site

Novosibirsk, Russia

Location

Novartis Investigator Site

Petrozavodsk, Russia

Location

Novartis Investigator Site

Ryazan, Russia

Location

Novartis Investigative Site

Saint Petersburg, Russia

Location

Novartis Investigator Site

Saint Petersburg, Russia

Location

Novartis Investigator Site

Samara, Russia

Location

Novartis Investigator Site

Yekaterinburg, Russia

Location

Novartis Investigator Site

Bratislava, Slovakia

Location

Novartis Investigative Site

Košice, Slovakia

Location

Novartis Investigator Site

Košice, Slovakia

Location

Novartis Investigator Site

Kráľovský Chlmec, Slovakia

Location

Novartis Investigator Site

Nitra, Slovakia

Location

Novartis Investigative Site

Prešov, Slovakia

Location

Novartis Investigator Site

Zvolen, Slovakia

Location

Novartis Investigative Site

Alcorcón, Spain

Location

Novartis Investigator Site

Alicante, Spain

Location

Novartis Investigator Site

Badalona, Spain

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Investigative Site

Begonte, Spain

Location

Novartis Investigator Site

Burgos, Spain

Location

Novartis Investigator Site

Canet de Mar, Spain

Location

Novartis Investigator Site

Cáceres, Spain

Location

Novartis Investigator Site

el Prat de Llobregat, Spain

Location

Novartis Investigative Site

Fuenlabrada, Spain

Location

Novartis Investigative Site

Girona, Spain

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigator Site

Mataró, Spain

Location

Novartis Investigator Site

Plasencia, Spain

Location

Novartis Investigative Site

Ponferrada, Spain

Location

Novartis Investigative Site

Pontevedra, Spain

Location

Novartis Investigative Site

Santander, Spain

Location

Novartis Investigative Site

Valencia, Spain

Location

Novartis Investigative Site

Vila-real, Spain

Location

Novartis Investigator Site

Basel, Switzerland

Location

Novartis Investigator Site

Bellinzona, Switzerland

Location

Novartis Investigator Site

Lugano, Switzerland

Location

Novartis Investigator Site

Muenchenstein, Switzerland

Location

Novartis Investigative Site

Zurich, Switzerland

Location

Novartis Investigator Site

Altunizade, Turkey (Türkiye)

Location

Novartis Investigator Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Aydin, Turkey (Türkiye)

Location

Novartis Investigator Site

Büyükçekmece / Ýstanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Fatih / Istanbul, Turkey (Türkiye)

Location

Novartis Investigator Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigator Site

Kahramanmaraş, Turkey (Türkiye)

Location

Novartis Investigative Site

Mecidiyekoy/Istanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Mersin, Turkey (Türkiye)

Location

Novartis Investigative Site

Soke / Aydin, Turkey (Türkiye)

Location

Novartis Investigative Site

Yenisehir/Izmir, Turkey (Türkiye)

Location

Novartis Investigator Site

Ash Vale, United Kingdom

Location

Novartis Investigator Site

Ashford, United Kingdom

Location

Novartis Investigator Site

Bolton, United Kingdom

Location

Novartis Investigator Site

Boscastle, United Kingdom

Location

Novartis Investigator Site

Bradford, United Kingdom

Location

Novartis Investigator Site

Chertsey, United Kingdom

Location

Novartis Investigator Site

East Horsley, United Kingdom

Location

Novartis Investigator Site

Newcastle upon Tyne, United Kingdom

Location

Novartis Investigator Site

Plymouth, United Kingdom

Location

Novartis Investigator Site

Watford, United Kingdom

Location

Related Publications (1)

• Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.

  PMID: 21622587 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 19, 2011
• Results First Posted: August 19, 2011

Record last verified: 2011-07

Locations

NO (15); AU (3); ES (19); CH (5); DK (7); CA (7); HU (6); GR (1); IL (2); CO (3); ME (3); FI (6); PL (7); RU (9); SL (7); TU (11); DE (35); GB (10); BE (9); IT (8); FR (14); US (25)