Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

NCT03257995 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CQVM149B2203
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.

Conditions

Asthma

Keywords

asthma, asthma attack, difficulty breathing, bronchial diseases, lung, lung diseases, inhaled drugs, bronchodilator, inhaled corticosteriod

Outcome Measures

Primary Outcomes (1)

• Trough FEV1

  FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate

  Day 14 of each of the three treatment periods

Secondary Outcomes (15)

• Pharmacokinetics AUC 0-24hours at Steady State

  Day 14 of each of the three treatment periods

• The Maximum Concentration (Cmax) at Steady State (ss)

  Day 14 of each of the three treatment periods

• Time of Maximal Plasma Concentration (Tmax) at Steady State

  Day 14 of each of the three treatment periods

• The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State

  Day 14 of each of the three treatment periods

• Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate

  Day 14

Study Arms (6)

Sequence 1

EXPERIMENTAL

A-B-C

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Sequence 2

EXPERIMENTAL

B-C-A

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Sequence 3

EXPERIMENTAL

C-A-B

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Sequence 4

EXPERIMENTAL

A-C-B

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Sequence 5

EXPERIMENTAL

B-A-C

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Sequence 6

EXPERIMENTAL

C-B-A

Drug: Indacaterol maleate; Drug: Indacaterol acetate; Drug: Placebo

Interventions

Indacaterol maleate DRUG

150 μg via Concept1 device

Also known as: A

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Indacaterol acetate DRUG

150 μg via Concept1 device

Also known as: B

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo DRUG

Capsule containing no active ingredients delivered via Concept1 device

Also known as: C

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

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

You may qualify if:

• Male and female patients aged ≥ 18 and above
• Patients with a documented physician diagnosis of asthma for a period of at least 1 year prior to screening and who additionally meet the following criteria:
• Patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks prior to screening.
• Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient during screening.
• Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at screening.
• Subjects must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.

You may not qualify if:

• Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
• Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of screening.
• Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to screening.
• Patients with a history of chronic lung diseases other than asthma
• Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30% for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening) during at least 3 days of screening epoch prior to randomization.
• Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) during screening prior to randomization.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c \> 9%) at screening.
• Current smokers (urine cotinine \> than the laboratory's lowest level of quantification (LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

North Dartmouth, Massachusetts, 02747-3322, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Skillman, New Jersey, 08558, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504, United States

Location

Novartis Investigative Site

El Paso, Texas, 79903, United States

Location

Related Publications (1)

• Miller D, Vaidya S, Jauernig J, Ethell B, Wagner K, Radhakrishnan R, Tillmann HC. Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients. Respir Res. 2020 Sep 23;21(1):248. doi: 10.1186/s12931-020-01501-1.

  PMID: 32967685 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com

MeSH Terms

Conditions

Asthma; Dyspnea; Bronchial Diseases; Lung Diseases

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: August 22, 2017
• Study Start: September 5, 2017
• Primary Completion: January 17, 2018
• Study Completion: January 18, 2018
• Last Updated: January 5, 2021
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Locations

US (6)