Clinical trial NCT01566604: Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Official title: A 26-week Treatment, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 (50 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
NVA237
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 460
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* With moderate to severe stable COPD (Stage II or Stage III).
* Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
* Post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/FVC \< 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).
* Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

* With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count \>600/mm3 at Visit 2 are excluded.
* Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.
* Patients with lung lobectomy or lung volume reduction or lung transplantation.
* Patients with known history and diagnosis of α-1 antitrypsin deficiency.
* Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1)
timeFrame: 12 weeks
Secondary outcomes:
measure: Transition Dyspnea Index (TDI) Score
timeFrame: Baseline, week 12, week 26
measure: Change From Baseline in Daily Rescue Medication Use (Number of Puffs)
timeFrame: Baseline, 26 weeks
measure: 24h Trough FEV1
timeFrame: Day 1, Week 26
measure: FEV1 and Forced Vital Capacity (FVC)
timeFrame: Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose
measure: Peak FEV1
timeFrame: Day 1, week 12, week 26
measure: Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose
timeFrame: Day 1, week 12, week 26
measure: Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)
timeFrame: Baseline, 26 weeks
measure: Time to First Moderate or Severe COPD Exacerbation
timeFrame: 26 weeks
measure: Number of Moderate and Severe COPD Exacerbations
timeFrame: 26 weeks
measure: The Total Score of the St George's Respiratory Questionnaire (SGRQ)
timeFrame: Week 12, week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Nanning
country: China
facility: Novartis Investigative Site
state: Guangxi
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Changsha City
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Shengyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Guang zhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Dehli
country: India
facility: Novartis Investigative Site
state: New Delhi
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bulacan
country: Philippines
facility: Novartis Investigative Site
city: Las Pinas
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: