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Phase 3 Completed N=89 Randomized Triple-blind Treatment

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Source: ClinicalTrials.gov NCT00669617 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose — 1.48; 1.50; 1.38; 1.43 Liters

Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Outcome Measures

OutcomeResultp-value
PRIMARY
Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
1.48; 1.50; 1.38; 1.43; 1.47

Eligibility Criteria

Inclusion Criteria

  • Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
  • Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:
  • Smoking history of at least 20 pack years
  • Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) 400/mm3; onset of asthma symptoms prior to age 40 years
  • History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (>450ms for males or >470ms for females)
  • Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
  • Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0% of total hemoglobin measured at Visit 2
  • Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time
  • History of hypersensitivity to any of the study drugs
  • Irregular day/night, waking/sleeping cycles e.g. shift workers
  • Live attenuated vaccinations within 30 days prior to Visit 2
  • Investigational drug within 30 days prior to Visit 2
  • Known history of non-compliance or not able to use devices or perform spirometry

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00669617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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