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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Indacaterol (Drug); Placebo (Drug); Salmeterol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigative site

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Maximum Heart Rate During Exercise in Part 1

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

Secondary outcome:

Change in Heart Rate During Exercise in Part 1

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

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative site, Antwerp, Belgium
Additional Information

Starting date: August 2007
Last updated: April 23, 2012

Page last updated: August 23, 2015

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