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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 has been completed.
First Received: September 17, 2007   Last Updated: July 15, 2008   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00531050
  Purpose

This study will investigate 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 or placebo and salmeterol.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: QAB149
Drug: Placebo
Drug: Salmeterol
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • • Effect of exercise on maximal heart rate in patients with COPD receiving therapeutic doses of indacaterol and salmeterol • Effect of high-dose salbutamol on maximal heart rate [ Time Frame: End of study ]

Secondary Outcome Measures:
  • • Cardiovascular safety of therapeutic doses of indacaterol and salmeterol • Exercise effect on change in heart rate from pre-exercise • Non-cardiovascular safety and tolerability • Bronchodilator efficacy [ Time Frame: End of study ]

Estimated Enrollment: 24
Study Start Date: August 2007
Study Completion Date: June 2008
Arms Assigned Interventions
1: Experimental
QAB149
Drug: QAB149
2: Placebo Comparator
Placebo
Drug: Placebo
3: Active Comparator
Salmeterol
Drug: Salmeterol

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 40 and 75 years of age diagnosed with 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 personal or close family (grandparents, parents and siblings) medical history of heart abnormalities, heart attacks, or heart disease, including irregular heartbeats and exercise-induced angina.
  • Any medical condition that may interfere with exercise testing such as. 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 condition that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531050

Locations
Belgium
Novartis Investigative site
Antwerp, Belgium
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CQAB149B2217
Study First Received: September 17, 2007
Last Updated: July 15, 2008
ClinicalTrials.gov Identifier: NCT00531050     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
COPD
cycle ergometry
exercise testing
spirometry
cardiovascular
salbutamol
indacaterol
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Albuterol
Physiological Effects of Drugs
Anti-Asthmatic Agents
Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010