Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01609478
First received: April 23, 2012
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: indacaterol Drug: placebo Drug: mometasone furoate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Trough Forced Expiratory Volume in one second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
Secondary Outcome Measures:
- Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.
Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
- Trough FEV1 [ Time Frame: 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 50 minute and 15 minute pre dose FEV1 readings for 4 weeks and as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings for 2weeks and 8weeks.
- Forced vital capacity (FVC) at each timepoint [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 29, Day 57, Day 84, Day 85 ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 6 hour on Day 1, Day 14 and Day 84, at post dose 23 hour 10 minute and 23 hour 45 minutes on Day 2, Day 15 and Day 85, and at pre-dose 50 min and 15 min on Day 29 and Day 57.
- FEV1/FVC at each timepoint [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 29, Day 57, Day 84, Day 85 ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 6 hour on Day 1, Day 14 and Day 84, at post dose 23 hour 10 minute and 23 hour 45 minutes on Day 2, Day 15 and Day 85, and at pre-dose 50 min and 15 min on Day 29 and Day 57.
- Standardized FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) [ Time Frame: Day 1, 2 Weeks, 12 Weeks ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1 and 2 Weeks and 12 Weeks and defined as average of FEV1 at specified timepoints above.
- Peak FEV1 [ Time Frame: Day 1, 2 Weeks, 12 Weeks ] [ Designated as safety issue: No ]Spirometry is conducted according to the global standard. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
- Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 4 Weeks, 8 Weeks ] [ Designated as safety issue: No ]
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.
Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
- Morning and evening peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PEFR is measured with portable spirometer by participants every morning and evening at home.
- The usage of rescue medication (short acting β2-agonist) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening.
- Asthma Quality of Life Questionnaire (AQLQ(S)) [ Time Frame: 4 Weeks, 12 Weeks ] [ Designated as safety issue: No ]The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
- Adverse events, laboratory analysis, vital signs and ECG [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Adverse event, laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (i.e. blood pressure, pulse rate), and ECG (e.g. quantitative assessments - heart rate, QTc, PRS, PR intervals).
- Plasma Indacaterol concentrations [ Time Frame: Day 1, Day 14 ] [ Designated as safety issue: Yes ]Indacaterol concentrations will be measured from pre-dose to 23h25min post -dose on Day 1 and Day 14.
- Time to first asthma exacerbation (mild, moderate, severe, moderate or severe and any) during the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- The annual rate of asthma exacerbations (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- Duration of asthma exacerbations (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- The percentage of patients with at least one asthma exacerbation (mild, moderate, severe, moderate or severe and any) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- Time to permanent study discontinuation due to asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- The percentage of patients who permanently discontinued study due to asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
- Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
| Estimated Enrollment: | 330 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: indacaterol acetate 75 µg
indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
Drug: indacaterol
indacaterol acetate 150 µg indacaterol delivered via Concept 1 inhaler
Drug: mometasone furoate
via Twisthaler inhaler
|
|
Experimental: indacaterol acetate 150 µg
indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
Drug: indacaterol
indacaterol acetate 150 µg indacaterol delivered via Concept 1 inhaler
Drug: mometasone furoate
via Twisthaler inhaler
|
|
Placebo Comparator: placebo
placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
Drug: placebo
placebo delivered via Concept 1 inhaler
Drug: mometasone furoate
via Twisthaler inhaler
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
- Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
- Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
- ACQ-5 score ≥ 1.5
Exclusion Criteria:
- Patients who are current smokers or 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).
- Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609478
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Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
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| Bulgaria | |
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| Pleven, Bulgaria, 5800 | |
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| Plovdiv, Bulgaria, 400 | |
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| Plovdiv, Bulgaria, 4001 | |
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| Plovdiv, Bulgaria, 4002 | |
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| Topolcany, Slovakia, 955 01 | |
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| Zvolen, Slovakia, 960 01 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01609478 History of Changes |
| Other Study ID Numbers: | CQMF149E2203, 2012-000520-18 |
| Study First Received: | April 23, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Japan: Pharmaceuticals and Medical Devices Agency Latvia: State Agency of Medicines Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control Bulgaria: Bulgarian Drug Agency Korea: Food and Drug Administration |
Keywords provided by Novartis:
|
asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013