QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)
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| ClinicalTrials.gov Identifier: NCT01315249 |
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Recruitment Status :
Completed
First Posted : March 15, 2011
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: indacaterol and glycopyrronium (QVA149) Drug: Placebo to fluticasone/salmeterol Drug: fluticasone/salmeterol Drug: Placebo to indacaterol and glycopyrronium (QVA149) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 523 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease |
| Study Start Date : | March 2011 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: QVA149
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
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Drug: indacaterol and glycopyrronium (QVA149)
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily. Drug: Placebo to fluticasone/salmeterol Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily. |
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Active Comparator: fluticasone/salmeterol
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
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Drug: fluticasone/salmeterol
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily. Drug: Placebo to indacaterol and glycopyrronium (QVA149) Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily |
Primary Outcome Measures :
- Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 [ Time Frame: Week 26 ]Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
Secondary Outcome Measures :
- Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours [ Time Frame: Week 12 ]Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
- Forced Vital Capacity at All-time Points (Week 12) [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 ]
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.
- Forced Vital Capacity at All-time Points (Week 26) [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 ]
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.
- Focal Score of the Transitional Dyspnea Index (TDI) [ Time Frame: 12 weeks and 26 weeks ]Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
- Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 12 weeks and 26 weeks ]The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
- Mean Change From Baseline in Daily Number of Puffs of Rescue Medication [ Time Frame: Baseline, 12 weeks and 26 weeks ]Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
- Change From Baseline in Symptom Scores Reported Using the Ediary [ Time Frame: 12 weeks and 26 weeks ]
Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.
Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.
0 is the minimum score = "none" or "No symptoms" or "never" or "No"
- = mild, a little
- = moderate
- = severe For the scale range provided, high values represent a worse outcome.
- Inspiratory Capacity (IC) at All-time Points (12 Weeks) [ Time Frame: 12 weeks ]After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
- Inspiratory Capacity (IC) at All-time Points (26 Weeks) [ Time Frame: 26 weeks ]After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
- Number of Participants With Adverse Events [ Time Frame: 26 weeks ]The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Smoking history of at least 10 pack years
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%
Exclusion Criteria:
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer (within last 5 years)
- Patients with a history of certain cardiovascular co-morbid conditions
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315249
Locations
Show 92 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01315249 |
| Other Study ID Numbers: |
CQVA149A2313 2010-023621-37 ( EudraCT Number ) |
| First Posted: | March 15, 2011 Key Record Dates |
| Results First Posted: | August 9, 2013 |
| Last Update Posted: | August 9, 2013 |
| Last Verified: | July 2013 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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QVA149 indacaterol NVA237 COPD fluticasone/salmeterol |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Chronic Disease Disease Attributes Pathologic Processes Fluticasone Xhance Glycopyrrolate Salmeterol Xinafoate Fluticasone-Salmeterol Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Muscarinic Antagonists Cholinergic Antagonists |