Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: indacaterol maleate / mometasone furoate; Drug: placebo to indacaterol/mometasone; Drug: placebo to fluticasone propionate/salmeterol; Drug: fluticasone propionate/salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557440

CQMF149A2202

Details and patient eligibility

About

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure,

• Patients with persistent asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:

  • Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to Visit 1.
  • Patients with an FEV1 at Visit 1 ≥50% of predicted normal.
  • Patients who demonstrate an increase of ≥ 12% and ≥ 200 mL in FEV1 over their pre-bronchodilator.

Exclusion criteria

• Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
• Patients who have used tobacco products within the 6 months period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
• Patients diagnosed with Chronic Obstructive Pulmonary disease (COPD) as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2006).
• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
• Patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1.
• Patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
• Patients with a history of long QT interval syndrome or whose QT interval corrected for heart rate (QTc) interval (Bazett's) measured at Visit 1 or Visit 2 is prolonged: > 450 ms (males) or > 470 ms (females).
• Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups

Ind/M - FP/Salm - Pbo

Experimental group

Description:

In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period.

Treatment:

Drug: placebo to indacaterol/mometasone

Drug: fluticasone propionate/salmeterol

Drug: indacaterol maleate / mometasone furoate

Drug: placebo to fluticasone propionate/salmeterol

FP/Salm - Pbo - Ind/M

Experimental group

Description:

In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period.

Treatment:

Drug: placebo to indacaterol/mometasone

Drug: fluticasone propionate/salmeterol

Drug: indacaterol maleate / mometasone furoate

Drug: placebo to fluticasone propionate/salmeterol

Pbo - Ind/M - FP/Salm

Experimental group

Description:

In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period.

Treatment:

Drug: placebo to indacaterol/mometasone

Drug: fluticasone propionate/salmeterol

Drug: indacaterol maleate / mometasone furoate

Drug: placebo to fluticasone propionate/salmeterol