Efficacy and Safety of Different Doses of Indacaterol

Novartis

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Indacaterol; Drug: Placebo to Salmeterol; Drug: Salmeterol; Drug: Placebo to Indacaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079130

CQAB149B2357

Details and patient eligibility

About

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of asthma, and:

  1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
  3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion criteria

• Smoking history >10 pack-years
• Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
• Patients who have had an intubation for a severe asthma exacerbation
• Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular comorbid conditions
• Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

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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511 participants in 6 patient groups, including a placebo group

Indacaterol 18.75 µg

Experimental group

Description:

Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Salmeterol

Drug: Indacaterol

Indacaterol 37.5 µg

Experimental group

Description:

Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Salmeterol

Drug: Indacaterol

Indacaterol 75 µg

Experimental group

Description:

Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Salmeterol

Drug: Indacaterol

Indacaterol 150 µg

Experimental group

Description:

Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Salmeterol

Drug: Indacaterol

Salmeterol

Active Comparator group

Description:

Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Indacaterol

Drug: Salmeterol

Placebo

Placebo Comparator group

Description:

Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to Salmeterol

Drug: Placebo to Indacaterol