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OpenTrials
Completed

NCT Number: NCT01079130

Efficacy and Safety of Different Doses of Indacaterol

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigator Site, Glendale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of asthma, and:
  • Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  • Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
  • An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion criteria

  • Smoking history >10 pack-years
  • Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
  • Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
  • Patients who have had an intubation for a severe asthma exacerbation
  • Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions
  • Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Indacaterol

Drug

Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.

Salmeterol

Drug

50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

Placebo to Indacaterol

Drug

Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.

Placebo to Salmeterol

Drug

Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).

Primary outcomes

  1. Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment

    Time frame: Day 15 (after 2 weeks of treatment)

    Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.

Secondary outcomes

  1. Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment

    Time frame: Day 2 (after 1 day of treatment)

    Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

Important dates

Study start
2010
Primary completion
2010
First posted
Mar 2, 2010
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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