Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease INTRUST1
- Conditions
- J449-J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecified
- Registration Number
- PER-049-09
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Male and female adults aged 40 years and over, who have signed an Informed Consent Form prior to initiation of any study-related activities
• Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2007, Appendix 2) and including: a) Smoking history of at least 10 pack years, both current and ex-smokers are eligible b) Post-bronchodilator FEV1 =65% and = 30% of the predicted normal value (Visit 2) c) Post-bronchodilator FEV1/FVC < 70% (Visit 2)
• Pregnant or breastfeeding women (breastfeeding), where pregnancy is defined as the status of a woman after conception and until the end of pregnancy, confirmed by a laboratory test of positive human chorionic gonadotropin in the serum (> 5 mlU / mL).
• Women with reproductive potential, defined as all women physiologically capable of becoming pregnant, including those whose career, lifestyle or sexual orientation impede sexual relations with a male partner and women whose partner has been sterilized by a vasectomy or by other means, EXCEPT that they meet the following definition of postmenopausal woman: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels> 40 mlU / mL or that are using one or more of the following methods of acceptable contraception: a) surgical sterilization (for example, bilateral tubal ligation, hysterectomy) b) hormonal contraception (implant, patch, oral) or) double barrier methods (any double combination of: IUD, male or female condom with ge spermatizide, diaphragm, sponge, cervical cap) Acceptable methods of contraception may include ab Total relevance at the discretion of the investigator in cases where the patient´s age, career, lifestyle or sexual orientation ensures compliance. Periodic abstinence (e.g., calendar, ovulation, synergistic, post-ovulation methods) and periodic withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained during the study and for 30 days after discontinuation of the medication.
• Patients with a body mass index (BMI) of less than 15 or greater than 40 kg / m
• Patients who have had an exacerbation of COPD that has required systemic treatment with glucocorticoids or antibiotics and / or hospitalization in the 6 weeks prior to selection (Visit 2). In the event that the exacerbation occurs during the period of admission (Visits 2-4), the patient should discontinue the study. The patient can be re-selected once the inclusion / exclusion criteria have been met.
• Patients requiring oxygen therapy for chronic hypoxemia (excluding acute exacerbation of COPD). These are patients that typically require oxygen therapy> 15 h per day administered by an oxygen cylinder or concentrator at home.
• Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection between Visit 2 and Visit 4 should be discontinued from the study, but they may be re-admitted. select once the inclusion / exclusion criteria have been met.
• Patients with concomitant lung disease, pulmonary tuberculosis (unless confirmed by chest radiography that is no longer active) or clinically significant bronchiectasis.
• Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to): a. Beginning of respiratory symptoms (such as cough, wheezing, shortness of breath) suggestive of asthma before age 40. b. Asthma diagnosis history
• Patients with Type I diabetes or Type I diabetes! uncontrolled including patients with a history of blood glucose levels consistently outside the normal range or of an HbAlc> B.0% of the total Hb measured at Visit 2.
• Patients with contraindications to treatment with tiotropium including a medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow angle glaucoma and moderate to severe renal impairment (creatinine clearance <50 mL / min)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.<br><br>Measure:Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)<br>Timepoints:From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)<br>
- Secondary Outcome Measures
Name Time Method