Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00677807 | Completed Phase 3 Results

• 2 other identifiers: CQAB149B2335SE2008-000663-42
• Study Type: interventional
• Target: 415
• Locations: 9 countries
• Sites: 190

Brief Summary

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Conditions

COPD

Keywords

COPD; adults; β2-agonist; indacaterol

Outcome Measures

Primary Outcomes (6)

• The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

  The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate: \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm.

  Up to 52 weeks

• The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

  The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \<75 mmHg or \<= to 90 mmHg and a decrease from baseline \>= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \>200 mmHg or \>= to 180 mmHg and an increase from baseline \>= to 20 mmHg.

  Up to 52 weeks

• The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

  The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \<40 mmHg or \<= to 50 mmHg and a decrease from baseline \>= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \>115 mmHg or \>= to 105 mmHg and an increase from baseline \>= to 15 mmHg.

  Up to 52 weeks

• The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

  The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= \>450 ms for males and \>470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \>60 ms.

  Up to 52 weeks

• Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52

  The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.

  Weeks 12, 26, 36, 44 and 52

• Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52

  The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.

  Weeks 12, 26, 36, 44 and 52

Secondary Outcomes (2)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment

  Week 52

• Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52

  Weeks 36, 44 and 52

Study Arms (3)

Indacaterol 150 µg

EXPERIMENTAL

Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol

Indacaterol 300 µg

EXPERIMENTAL

Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol

Placebo

PLACEBO COMPARATOR

Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Drug: Placebo

Interventions

Indacaterol DRUG

Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Indacaterol 150 µg; Indacaterol 300 µg

Placebo DRUG

Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Placebo

Eligibility Criteria

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

You may not qualify if:

• Patients must complete Stage 2 of the core study B2335S (NCT00463567).
• Written informed consent to participate in the extension must be obtained.
• Patients must be able to comply with all study requirements.
• Patients who were randomized to open-label tiotropium in Study B2335S.
• Patients who participated in Stage 1 of the core study (B2335S).
• Patients discontinued irrespective of the reason from Stage 2 of the core study.
• Patients who fail to comply with the core protocol requirements and procedures.
• Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
• Patients who in the Investigator's opinion should not participate in the extension study.

Sponsors & Collaborators

• Novartis: lead

Study Sites (190)

Novartis Investigative Site

Homewood, Alabama, 35209-6870, United States

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Jasper, Alabama, 35501, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85712, United States

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Pine Bluff, Arkansas, 71603, United States

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Encinitas, California, 92024-1332, United States

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Fullerton, California, 92835, United States

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Orange, California, 92869, United States

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Riverside, California, 92506, United States

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Spring Valley, California, 91978, United States

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Fort Collins, Colorado, 80528, United States

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Golden, Colorado, 80401, United States

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Wheat Ridge, Colorado, 80033, United States

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Clearwater, Florida, 33765, United States

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Largo, Florida, 33770, United States

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Pensacola, Florida, 32504, United States

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Rockledge, Florida, 32955, United States

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South Miami, Florida, 33143, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33603, United States

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Atlanta, Georgia, 30342, United States

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Marietta, Georgia, 30060, United States

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Normal, Illinois, 61761, United States

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O'Fallon, Illinois, 62269, United States

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River Forest, Illinois, 60305, United States

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Indianapolis, Indiana, 46256, United States

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Iowa City, Iowa, 52240, United States

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Iowa City, Iowa, 52242, United States

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Topeka, Kansas, 66606, United States

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Crescent Springs, Kentucky, 41017, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40536, United States

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Lafayette, Louisiana, 70503, United States

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Metaire, Louisiana, 70002, United States

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New Orleans, Louisiana, 70112, United States

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Biddeford, Maine, 04005, United States

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Clarkston, Michigan, 48346, United States

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Flint, Michigan, 48532, United States

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Livonia, Michigan, 48152, United States

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Troy, Michigan, 48085, United States

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Minneapolis, Minnesota, 55402, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905, United States

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Chesterfield, Missouri, 63017, United States

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Columbia, Missouri, 65212, United States

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Kansas City, Missouri, 64108-2677, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Kalispell, Montana, 59901, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68130, United States

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Omaha, Nebraska, 68134, United States

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Omaha, Nebraska, 68198-5885, United States

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Papillion, Nebraska, 68046, United States

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Henderson, Nevada, 89014, United States

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Summit, New Jersey, 07901, United States

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Elmira, New York, 14905, United States

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New York, New York, 10016, United States

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Rochester, New York, 14618-2638, United States

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Charlotte, North Carolina, 28207, United States

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Shelby, North Carolina, 28150, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58122, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44109-1998, United States

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Columbus, Ohio, 43213, United States

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Columbus, Ohio, 43215, United States

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Marion, Ohio, 43302, United States

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Sylvania, Ohio, 43650, United States

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Thornville, Ohio, 43076, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73104, United States

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Tulsa, Oklahoma, 74135-2920, United States

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Eugene, Oregon, 97404-3233, United States

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Medford, Oregon, 97504-8741, United States

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Erie, Pennsylvania, 16506, United States

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Pittsburgh, Pennsylvania, 15221, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Cranston, Rhode Island, 02920, United States

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Cumberland, Rhode Island, 02864, United States

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Greenville, South Carolina, 29615, United States

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Johnson City, Tennessee, 37601, United States

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Corsicana, Texas, 75110, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79902, United States

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Fort Worth, Texas, 76104, United States

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San Antonio, Texas, 78229, United States

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Abingdon, Virginia, 24210, United States

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Lynchburg, Virginia, 24501, United States

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Richmond, Virginia, 23249, United States

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Bellingham, Washington, 98225, United States

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Spokane, Washington, 99216, United States

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Milwaukee, Wisconsin, 53209-0996, United States

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Buenos Aires, Argentina

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Rosario, Argentina

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Ajax, Canada

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Calgary, Canada

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Gatineau, Canada

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Moncton, Canada

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Montreal, Canada

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Niagara Falls, Canada

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Ottawa, Canada

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Québec, Canada

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Saint Romuald, Canada

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Saskatoon, Canada

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Sherbrooke, Canada

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St. John's, Canada

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Toronto, Canada

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Trois-Rivières, Canada

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Vancouver, Canada

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Windsor, Canada

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Winnipeg, Canada

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Augsburg, Germany

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Bad Segeberg, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bonn, Germany

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Dachau, Germany

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Hamburg, Germany

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Hoyerswerda, Germany

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Kaufbeuren, Germany

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Landsberg, Germany

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Leipzig, Germany

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Mainz, Germany

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München, Germany

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Oranienburg, Germany

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Oschersleben, Germany

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Potsdam, Germany

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Ratingen, Germany

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Steinfurt-Borghorst, Germany

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Bangalore, India

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Chennai, India

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Coimbatore, India

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Coimbatore, India

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Hyderabaad, India

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Indore, India

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Jaipur, India

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Kolkata, India

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Ludhiana, India

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Mumbai, India

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Panjim, India

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Trivandrum, India

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Bologna, Italy

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Busto Arsizio, Italy

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Catania, Italy

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Catanzaro, Italy

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Crema, Italy

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Ferrara, Italy

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Florence, Italy

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Messina, Italy

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Milan, Italy

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Pisa, Italy

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Roma, Italy

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Rozzano, Italy

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Siena, Italy

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Sottomarina, Italy

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A Coruña, Spain

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Alicante, Spain

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Alzira, Spain

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Barcelona, Spain

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Burgos, Spain

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Córdoba, Spain

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Girona, Spain

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Gladakano, Spain

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Jerez de Frontera, Spain

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Las Palmas de Gran Canaria, Spain

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Las Palmas de Gran Canarias, Spain

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Lugo, Spain

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Madrid, Spain

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Málaga, Spain

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Ourense, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Ponferrada, Spain

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Pontevedra, Spain

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Port de Sagunt, Spain

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Seville, Spain

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Valencia, Spain

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Vic, Spain

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Vila-real, Spain

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Zaragoza, Spain

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Gothenburg, Sweden

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Jönköping, Sweden

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Lidingö, Sweden

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Luleå, Sweden

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Luleå, Sweden

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Lund, Sweden

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Kartal/Istanbul, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Yenisehir/Izmir, Turkey (Türkiye)

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Related Publications (1)

• Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B; INDORSE Study Investigators. Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011 Jul;140(1):68-75. doi: 10.1378/chest.10-1830. Epub 2011 Feb 24.

  PMID: 21349928 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 15, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 22, 2011
• Results First Posted: August 18, 2011

Record last verified: 2011-08

Locations

SE (6); IN (12); ES (25); US (93); DE (18); IT (14); TU (3); CA (17); AR (2)