Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
cycle ergometry
exercise testing
spirometry
cardiovascular
salbutamol
indacaterol
chronic obstructive pulmonary disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study
timeFrame: 24-hours post-dose on Day 1 (of each treatment)
measure: Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study
timeFrame: 24 hours post dose on Day 1
measure: Maximum Heart Rate During Exercise in Part 1
timeFrame: 2 hour post-dose on Day 1
measure: Maximum Heart Rate (HR) During Salbutamol Administration in Part 2
timeFrame: 24 hours post dose on Day 1
Secondary outcomes:
measure: Change in Heart Rate During Exercise in Part 1
timeFrame: 1.5 hour post dose to max heart rate during exercise
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2
timeFrame: 23 hours 30 minutes and 24 hours post-dose at Day 1
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Novartis Investigative site
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: