Phase 2
N=27
Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00531050 ↗Enrolled (actual)
27
Serious AEs
1.4%
Results posted
May 2012
Primary outcome: Primary: Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study — 20.00; 16.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Indacaterol (Drug); Placebo (Drug); Salmeterol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study |
20.00; 16.0 | — |
| PRIMARY Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study |
17.39; 17.39; 10.00; 25.00; 13.04; 17.39 | — |
| PRIMARY Maximum Heart Rate During Exercise in Part 1 |
133.13; 131.18; 129.96 | — |
| PRIMARY Maximum Heart Rate (HR) During Salbutamol Administration in Part 2 |
98.026; 98.087; 97.960; 97.179; 99.954; 97.786 | — |
| SECONDARY Change in Heart Rate During Exercise in Part 1 |
66.246; 64.265; 63.058 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2 |
1.72; 1.59; 1.56; 1.75; 1.68; 1.54 | — |
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
Data sourced from ClinicalTrials.gov (NCT00531050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.