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Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

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Novartis

Status and phase

Completed
Phase 2

Conditions

Persistent Asthma

Treatments

Drug: Indacaterol
Drug: Placebo to Indacaterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01156844
2010-018481-22 (EudraCT Number)
CQAB149B2223

Details and patient eligibility

About

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Enrollment

191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a diagnosis of asthma and:
  • Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  • FEV1 ≥50% and ≤90% of predicted normal at screening
  • An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion criteria

  • Smoking history of ≥ 10 years
  • Patients with a diagnosis of COPD
  • Patients who have been previously intubated for a severe asthma exacerbation/ attack
  • Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
  • Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
  • Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

191 participants in 4 patient groups, including a placebo group

Indacaterol 37.5 µg (twice a day)
Experimental group
Description:
Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Treatment:
Drug: Indacaterol
Indacaterol 75 µg (once a day)
Experimental group
Description:
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Treatment:
Drug: Placebo to Indacaterol
Drug: Indacaterol
Indacaterol 150 µg (every other day)
Experimental group
Description:
Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Treatment:
Drug: Placebo to Indacaterol
Drug: Indacaterol
Placebo
Placebo Comparator group
Description:
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Treatment:
Drug: Placebo to Indacaterol

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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