Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

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

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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