Status:
COMPLETED
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.
Detailed Description
This is a randomized, double-blind, placebo-controlled, three-period cross-over study in asthma patients. The study will consist of a screening epoch, followed by a treatment epoch which consists of t...
Eligibility Criteria
Inclusion
- Key
- Male and female patients aged ≥ 18 and above
- Patients with a documented physician diagnosis of asthma for a period of at least 1 year prior to screening and who additionally meet the following criteria:
- Patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks prior to screening.
- Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient during screening.
- Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at screening.
- Subjects must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.
- Key
Exclusion
- Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
- Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of screening.
- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to screening.
- Patients with a history of chronic lung diseases other than asthma
- Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30% for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening) during at least 3 days of screening epoch prior to randomization.
- Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) during screening prior to randomization.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c \> 9%) at screening.
- Current smokers (urine cotinine \> than the laboratory's lowest level of quantification (LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.).
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03257995
Start Date
September 5 2017
End Date
January 18 2018
Last Update
January 5 2021
Active Locations (6)
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1
Novartis Investigative Site
North Dartmouth, Massachusetts, United States, 02747-3322
2
Novartis Investigative Site
St Louis, Missouri, United States, 63141
3
Novartis Investigative Site
Skillman, New Jersey, United States, 08558
4
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607