Skip to main content
OpenTrials
Completed

NCT Number: NCT00531050

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative site

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol

Drug

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).

Placebo

Drug

Single dose indacaterol matching placebo via Concept 1 device

Salmeterol

Drug

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.

Primary outcomes

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

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

    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.

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

    Time frame: 24 hours post dose on Day 1

    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

  3. Maximum Heart Rate During Exercise in Part 1

    Time frame: 2 hour post-dose on Day 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.

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

    Time frame: 24 hours post dose on Day 1

    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.

Secondary outcomes

  1. Change in Heart Rate During Exercise in Part 1

    Time frame: 1.5 hour post dose to max heart rate during exercise

    Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.

    Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate.

  2. Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2

    Time frame: 23 hours 30 minutes and 24 hours post-dose at Day 1

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double-blind, Randomized, Cross-over, Placebo-controlled, 2-part Study to Compare the Effect of Exercise and High-dose Salbutamol on Maximal Heart-rate in Patients With COPD Following Therapeutic Doses of Inhaled QAB149 and Salmeterol

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2007
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.