Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

NCT01609478 | Completed Phase 2 Results

• 2 other identifiers: CQMF149E22032012-000520-18
• Study Type: interventional
• Target: 335
• Locations: 8 countries
• Sites: 96

Brief Summary

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.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)

  Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)

  after 12 weeks (Day 85)

Secondary Outcomes (19)

• Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)

  aftert 12 weeks (Day 85)

• Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.

  Day 15, Day 29 and Day 57

• Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points

  Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

• Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

  Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

• Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

  Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Study Arms (3)

indacaterol acetate 75 µg

EXPERIMENTAL

indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Drug: indacaterol; Drug: mometasone furoate

indacaterol acetate 150 µg

EXPERIMENTAL

indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Drug: indacaterol; Drug: mometasone furoate

placebo

PLACEBO COMPARATOR

placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Drug: placebo; Drug: mometasone furoate

Interventions

indacaterol DRUG

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler

indacaterol acetate 150 µg; indacaterol acetate 75 µg

placebo DRUG

placebo delivered via Concept 1 inhaler

placebo

mometasone furoate DRUG

via Twisthaler inhaler

indacaterol acetate 150 µg; indacaterol acetate 75 µg; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (96)

Novartis Investigative Site

Rousse, Bulgaria, 7002, Bulgaria

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Novartis Investigative Site

Sofia, Bulgaria, 1000, Bulgaria

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Sofia, Bulgaria, 1431, Bulgaria

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Novartis Investigative Site

Sofia, Bulgaria, 1463, Bulgaria

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Sofia, Bulgaria, 1606, Bulgaria

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Novartis Investigative Site

Sofia, Bulgaria, 1612, Bulgaria

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Novartis Investigative Site

Varna, Bulgaria, 9020, Bulgaria

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Novartis Investigative Site

Lovech, 5500, Bulgaria

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Novartis Investigative Site

Sofia, 1233, Bulgaria

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Novartis Investigative Site

Sofia, 1234, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Sofia, 1606, Bulgaria

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Novartis Investigative Site

Varna, 9000, Bulgaria

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Novartis Investigative Site

Veliko Tarnovo, 5000, Bulgaria

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Novartis Investigative Site

Brampton, Ontario, L6T 0G1, Canada

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Novartis Investigative Site

Downsview, Ontario, M3N 2Z9, Canada

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Etobicoke, Ontario, M9V 4B4, Canada

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Grimsby, Ontario, L3M 1P3, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Novartis Investigative Site

Ste-Foy, Quebec, G1W 4R4, Canada

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Novartis Investigative Site

Mainz, Germany, 55131, Germany

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Wiesbaden, Germany, 65187, Germany

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Novartis Investigative Site

Bad Wörishofen, 86825, Germany

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Bonn, 53123, Germany

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Dortmund, 44263, Germany

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Dresden, 01307, Germany

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Frankfurt, 60596, Germany

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Lübeck, 23552, Germany

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München, 81677, Germany

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Novartis Investigative Site

Wiesloch, 69168, Germany

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Fukuoka, Fukuoka, 811-1394, Japan

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Yanagawa, Fukuoka, 832-0059, Japan

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Gifu, Gifu, 502-8558, Japan

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Obihiro, Hokkaido, 080-0805, Japan

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Sapporo, Hokkaido, 060-0061, Japan

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Ako-shi, Hyōgo, 678-0241, Japan

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Himeji, Hyōgo, 672-8064, Japan

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Naka-gun, Ibaraki, 319-1113, Japan

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Sakaidechō, Kagawa-ken, 762-0031, Japan

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Kyoto, Kyoto, 615-8256, Japan

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Tsu, Mie-ken, 514-1101, Japan

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Beppu, Oita Prefecture, 874-0937, Japan

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Ōita, Oita Prefecture, 870-0021, Japan

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Novartis Investigative Site

Kishiwada, Osaka, 596-8501, Japan

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Chuo-ku, Tokyo, 103-0027, Japan

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Cyuo-ku, Tokyo, 104-8560, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Kiyose, Tokyo, 204-8585, Japan

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Setagaya-ku, Tokyo, 158-0097, Japan

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Machida-shi, Tokyo-To, 194-0023, Japan

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Ōta-ku, Tokyo-To, 144-0035, Japan

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Yonezawa, Yamagata, 992-0045, Japan

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Novartis Investigative Site

Rotterdam, 3045 PM, Netherlands

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Sittard-Geleen, 6162 BG, Netherlands

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Gdansk, Poland, 80-958, Poland

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Krakow, Poland, 31-023, Poland

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Bialystok, 15-461, Poland

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Bieńkówka, 34-212, Poland

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Bydgoszcz, 85-046, Poland

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Lodz, 90-242, Poland

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Lodz, 90-302, Poland

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Lublin, 20-044, Poland

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Lublin, 20-637, Poland

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Torun, 87-100, Poland

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Wroclaw, 50-088, Poland

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Żnin, 88-400, Poland

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Novartis Investigative Site

Banská Bystrica, Slovak Republic, 975 17, Slovakia

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Novartis Investigative Site

Bardejov, Slovak Republic, 085 01, Slovakia

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Novartis Investigative Site

Levice, Slovak Republic, 934 01, Slovakia

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Novartis Investigative Site

Košice, Slovakia, 040 01, Slovakia

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Novartis Investigative Site

Zvolen, Slovakia, 960 01, Slovakia

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Novartis Investigative Site

Dunajská Streda, 929 01, Slovakia

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Novartis Investigative Site

Komárno, 945 01, Slovakia

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Košice, 040 01, Slovakia

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Novartis Investigative Site

Liptovský Hrádok, 033 01, Slovakia

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Novartis Investigative Site

Liptovský Mikuláš, 031 23, Slovakia

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Novartis Investigative Site

Nové Zámky, 940 01, Slovakia

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Novartis Investigative Site

Rimavská Sobota, 979 01, Slovakia

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Novartis Investigative Site

Spisská Nová Ves, 052 01, Slovakia

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Novartis Investigative Site

Topoľčany, 955 01, Slovakia

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Novartis Investigative Site

Vyšné Hágy, 5984, Slovakia

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Novartis Investigative Site

Wŏnju, Gangwon-do, 220-701, South Korea

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Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

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Novartis Investigative Site

Cheongju-si, North Chungcheong, 361 711, South Korea

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Novartis Investigative Site

Seoul, 100-032, South Korea

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Novartis Investigative Site

Seoul, 120-752, South Korea

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Novartis Investigative Site

Seoul, 152-703, South Korea

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Novartis Investigative Site

Seoul, 158-710, South Korea

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MeSH Terms

Conditions

Asthma

Interventions

indacaterol; Mometasone Furoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

+1(862)778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: June 1, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 27, 2015
• Results First Posted: September 9, 2014

Record last verified: 2015-01

Locations

CA (12); PL (12); DE (10); KR (7); NL (2); BU (16); JP (22); SL (15)