Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: indacaterol; Drug: mometasone furoate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01609478

CQMF149E2203

2012-000520-18 (EudraCT Number)

Details and patient eligibility

About

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
• Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
• Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
• Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
• ACQ-5 score ≥ 1.5

Exclusion criteria

• Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
• Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
• Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

335 participants in 3 patient groups, including a placebo group

indacaterol acetate 75 µg

Experimental group

Description:

indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Treatment:

Drug: indacaterol

Drug: mometasone furoate

indacaterol acetate 150 µg

Experimental group

Description:

indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Treatment:

Drug: indacaterol

Drug: mometasone furoate

placebo

Placebo Comparator group

Description:

placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Treatment:

Drug: placebo

Drug: mometasone furoate