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Phase 3 Completed N=68 Randomized Quadruple-blind Treatment

A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Source: ClinicalTrials.gov NCT00622635 ↗
Enrolled (actual)
68
Serious AEs
0.5%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15) — 1.46; 1.26; 1.37 Liters

Summary

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.

Outcome Measures

OutcomeResultp-value
PRIMARY
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)
1.46; 1.26; 1.37
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)
1.44; 1.24; 1.36
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)
1.47; 1.27; 1.41
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)
1.49; 1.26; 1.42
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)
1.49; 1.26; 1.42
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.50; 1.27; 1.44
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.51; 1.29; 1.45
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.49; 1.29; 1.44
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.49; 1.26; 1.45
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.48; 1.29; 1.42
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.44; 1.27; 1.40
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.43; 1.25; 1.36
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)
1.45; 1.25; 1.35
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)
1.46; 1.24; 1.35
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)
1.45; 1.24; 1.39
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
1.36; 1.17; 1.31
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
1.40; 1.19; 1.35
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)
1.43; 1.25; 1.38
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
1.48; 1.24; 1.37
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
1.45; 1.28; 1.38

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
  • Smoking history of at least 20 pack-years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) 15 hours 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 (Bazett's) measured at screening or randomization 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

Other protocol-defined inclusion/exclusion criteria applied to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00622635). 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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