Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol

Novartis27 enrolled

Overview

This study investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

IndacaterolDRUG

Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).

PlaceboDRUG

Single dose indacaterol matching placebo via Concept 1 device

SalmeterolDRUG

Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception. * Body mass index (BMI) must be within the range of 18 to 32. Exclusion Criteria: * Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation. * Donation or loss of 400 mL or more of blood within two months prior to dosing. * Significant illness (other than respiratory) within two weeks prior to dosing. * A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening. * Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis. * History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). * A known hypersensitivity to the study drug or drugs similar to the study drug. * History of immunocompromise, including a positive HIV, Hepatitis B or C test result. * History of drug or alcohol abuse within the 12 months prior to dosing * Any conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial. Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Investigative site

Antwerp, Belgium

Outcomes

Primary Outcomes

Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study

The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.

Time frame: 24-hours post-dose on Day 1 (of each treatment)

Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study

The percentage of patients with an increase of \>= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined. * 0-12 hours: post first dose measurements up to second dose * 12-24 hours: post second dose measurement up to and including the 24 hour measurement * 0-24 hours: all post dose measurements up to and including the 24 hour measurement

Time frame: 24 hours post dose on Day 1

Maximum Heart Rate During Exercise in Part 1

Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.

Time frame: 2 hour post-dose on Day 1

Maximum Heart Rate (HR) During Salbutamol Administration in Part 2

Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.

Time frame: 24 hours post dose on Day 1

Secondary Outcomes

Data from ClinicalTrials.gov

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