COPD
Conditions
Keywords
COPD, Indacatarol, placebo, crossover, patient perception
Brief summary
This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.
Interventions
DRUGindacaterol
delivered via single-dose dry-powder inhaler
DRUGplacebo
delivered via single-dose dry-powder inhaler
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and: * Smoking history of at least 10 pack-years * Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40% of the predicted normal value * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70% * Breathing symptoms that interfere with daily activities
Exclusion criteria
* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * Patients who have had a respiratory tract infection within 6 weeks prior to screening * Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease * Patients with a history of asthma * Patients with uncontrolled diabetes mellitus * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Minutes) to Patient's Perception of Onset of Effect | 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2 | Defined as the first time point that the patient responds yes to the following self-administered question: I feel that the drug is working in improving my breathing? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol Then Placebo In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication. | 20 |
| Placebo Then Indacaterol In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment 2 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Indacaterol Then Placebo | Placebo Then Indacaterol | Total |
|---|---|---|---|
| Age Continuous | 62.2 years STANDARD_DEVIATION 10.29 | 60.8 years STANDARD_DEVIATION 6.9 | 61.5 years STANDARD_DEVIATION 8.68 |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Time (in Minutes) to Patient's Perception of Onset of Effect
Defined as the first time point that the patient responds yes to the following self-administered question: I feel that the drug is working in improving my breathing?
Time frame: 5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2
Population: Full Analysis Set included all participants who received one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| indacaterol_treatment 1 | Time (in Minutes) to Patient's Perception of Onset of Effect | 25.13 Minutes | Standard Deviation 27.726 |
| indacaterol_treatment 2 | Time (in Minutes) to Patient's Perception of Onset of Effect | 26.05 Minutes | Standard Deviation 28.787 |
| placebo_treatment 1 | Time (in Minutes) to Patient's Perception of Onset of Effect | 21.88 Minutes | Standard Deviation 25.928 |
| placebo_treatment 2 | Time (in Minutes) to Patient's Perception of Onset of Effect | 25.88 Minutes | Standard Deviation 27.449 |