Clinical trial NCT00677807: Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
adults
β2-agonist
indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 415
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
* In addition the following inclusion/exclusion criteria specified below must be met.

  1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).
  2. Written informed consent to participate in the extension must be obtained.
  3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 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
timeFrame: Up to 52 weeks
measure: 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
timeFrame: Up to 52 weeks
measure: 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
timeFrame: Up to 52 weeks
measure: 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
timeFrame: Up to 52 weeks
measure: Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
timeFrame: Weeks 12, 26, 36, 44 and 52
measure: Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
timeFrame: Weeks 12, 26, 36, 44 and 52
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment
timeFrame: Week 52
measure: Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52
timeFrame: Weeks 36, 44 and 52
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
country: United States
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city: Phoenix
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city: Tucson
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state: California
city: Fullerton
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state: California
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city: Spring Valley
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state: California
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city: Golden
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city: Wheat Ridge
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city: Clearwater
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city: Largo
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city: Pensacola
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city: Atlanta
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city: O'Fallon
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city: New Orleans
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city: Shelby
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city: Winston Salem
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country: Argentina
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country: Germany
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country: India
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city: Siena
country: Italy
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city: Sottomarina
country: Italy
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city: Alicante
country: Spain
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city: Alzira
country: Spain
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city: Barcelona
country: Spain
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city: Burgos
country: Spain
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city: Cordoba
country: Spain
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city: Girona
country: Spain
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city: Gladakano
country: Spain
facility: Novartis Investigator Site
city: Jerez de Frontera
country: Spain
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city: La Coruna
country: Spain
facility: Novartis Investigator Site
city: Las Palmas de Gran Canarias
country: Spain
facility: Novartis Investigator Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigator Site
city: Lugo
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Malaga
country: Spain
facility: Novartis Investigator Site
city: Orense
country: Spain
facility: Novartis Investigator Site
city: Oviedo
country: Spain
facility: Novartis Investigator Site
city: Palma De Mallorca
country: Spain
facility: Novartis Investigator Site
city: Ponferrada
country: Spain
facility: Novartis Investigator Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
city: Puerto de Sagunto
country: Spain
facility: Novartis Investigator Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Vic
country: Spain
facility: Novartis Investigator Site
city: Vila-real
country: Spain
facility: Novartis Investigator Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Jonkoping
country: Sweden
facility: Novartis Investigator Site
city: Lidingo
country: Sweden
facility: Novartis Investigative Site
city: Lulea
country: Sweden
facility: Novartis Investigative Site
city: Lulea
country: Sweden
facility: Novartis Investigator Site
city: Lund
country: Sweden
facility: Novartis Investigator Site
city: Kartal/Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigator Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.