A multi-center, randomized, double-blind, placebo-controlled, parallel group, repeated-dose study to evaluate the efficacy, safety, tolerability and pharmacokinetics of three different dosing regimens of inhaled indacaterol maleate in patients with persistent asthma
- Conditions
- Persistent asthmaMedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2010-018481-22-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
1. Male and female adult patients aged 18 years or above who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to the first study visit.
2. Patients with persistent asthma, diagnosed according to GINA guidelines 2008 and who additionally meet the following criteria:
• Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to first study visit.
• Patients with an FEV1 at screening of =50% and =90% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum of 48 hours for a long acting ß2-agonist and 7 days for tiotropium.
• Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 400 µg/360 µg of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period as described above. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at screening or between screening and pre-dose Day 1, in order for patients to be included in the trial.
3. Females patients may be included but must comply with the following in order to be included:
• Women of child-bearing potential (WOCBP) (defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means) may be included providing they are using two effective methods of contraception (for example oral contraceptive and
condom).. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Note: Reliable contraception must be maintained throughout the study.
• Postmenopausal women may be included providing they meet the following criteria:
12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous
amenorrhea with serum FSH levels >40 IU/L assessed at screening,
• Sterilized women may be included if they have undergone surgical bilateral
oophorectomy with or without hysterectomy at least 6-months previously.
4. BMI must be within the range 18-40 kg/m2 (inclusive).
5. Vital signs (after 3 minutes resting measured in the supine position) not considered by the Investigator to be indicative of a disorder which would make it unsafe for subject to participate in the study or require medical intervention.
6. Able to communicate well with the investigator and comply with the requirements of the study.
7. Male subjects must be using two highly effective methods of contraception, (comprising a barrier method condom or occlusive cap plus spermicide) plus ensure use by the female partner of a second method of contraception. These measures should be in place for the entire duration of the study up the Study Completion visit, and males should refrain from fathering a child in the three (3) months following the last study drug administration.
Are the trial subjects under 18? no
Number of subjects
1. Patients who have a smoking history of greater than 10 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). Current smokers who smoke greater than 10 cigarettes per day. Smokers should maintain their usual smoking habits throughout the course of the study.
2. Patients who have had previous intubation for a severe asthma attack/exacerbation.
3. Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to the first study visit.
4. Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to the first study visit or any time between the first study visit and pre-dose Day 1.
5. Patients who have had a lower respiratory tract infection within 6 weeks prior to the first study visit or any time between the first study visit and pre-dose Day 1.
6. Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
7. Patients who require the use of =8 inhalations per day of the short-acting ß2-agonist (100 µg/90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from screening to randomization.
8. Patients diagnosed with COPD as defined by the (GOLD Guidelines, 2009).
9. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active) or clinically significant bronchiectasis.
10. Any patient with lung cancer or a history of lung cancer.
(...)
29. Patients with a history of hypersensitivity or allergy to indacaterol or other similar drugs in its class or to the excipients (including lactose) of the drug product.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method